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Wikipedia

Electronic health record

October 14, 2023

This article is about all types of electronic health records. For prescriptions, see Electronic prescribing.

An electronic health record (EHR) is the systematized collection of patient and population electronically stored health information in a digital format.[1] These records can be shared across different health care settings. Records are shared through network-connected, enterprise-wide information systems or other information networks and exchanges. EHRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information.[2]

Sample view of an electronic health record

For several decades, electronic health records (EHRs) have been touted as key to increasing of quality care.[3] Electronic health records are used for other reasons than charting for patients;[4] today, providers are using data from patient records to improve quality outcomes through their care management programs. EHR combines all patients demographics into a large pool, and uses this information to assist with the creation of "new treatments or innovation in healthcare delivery" which overall improves the goals in healthcare.[4] Combining multiple types of clinical data from the system's health records has helped clinicians identify and stratify chronically ill patients. EHR can improve quality care by using the data and analytics to prevent hospitalizations among high-risk patients.

EHR systems are designed to store data accurately and to capture the state of a patient across time. It eliminates the need to track down a patient's previous paper medical records and assists in ensuring data is up-to-date,[5] accurate and legible. It also allows open communication between the patient and the provider, while providing "privacy and security."[5] It can reduce risk of data replication as there is only one modifiable file, which means the file is more likely up to date and decreases risk of lost paperwork and is cost efficient.[5] Due to the digital information being searchable and in a single file, EMRs (electronic medical records) are more effective when extracting medical data for the examination of possible trends and long term changes in a patient. Population-based studies of medical records may also be facilitated by the widespread adoption of EHRs and EMRs.

Terminology Edit

The terms EHR, electronic patient record (EPR) and EMR have often been used interchangeably, but differences between the models are now being defined. The electronic health record (EHR) is a more longitudinal collection of the electronic health information of individual patients or populations. The EMR, in contrast, is the patient record created by providers for specific encounters in hospitals and ambulatory environments and can serve as a data source for an EHR.[6][7]

In contrast, a personal health record (PHR) is an electronic application for recording personal medical data that the individual patient controls and may make available to health providers.[8]

Comparison with paper-based records Edit

While there is still a considerable amount of debate around the superiority of electronic health records over paper records, the research literature paints a more realistic picture of the benefits and downsides.[9]

The increased transparency, portability, and accessibility acquired by the adoption of electronic medical records may increase the ease with which they can be accessed by healthcare professionals, but also can increase the amount of stolen information by unauthorized persons or unscrupulous users versus paper medical records, as acknowledged by the increased security requirements for electronic medical records included in the Health Information and Accessibility Act and by large-scale breaches in confidential records reported by EMR users.[10][11] Concerns about security contribute to the resistance shown to their adoption.[weasel words] When users log in into the electronic health records, it is their responsibility to make sure the information stays confidential and this is done by keeping their passwords unknown to others and logging off before leaving the station.[12]

Handwritten paper medical records may be poorly legible, which can contribute to medical errors.[13] Pre-printed forms, standardization of abbreviations and standards for penmanship were encouraged to improve the reliability of paper medical records. An example of possible medical errors is the administration of medication. Medication is an intervention that can turn a person's status from stable to unstable very quickly. With paper documentation it is very easy to not properly document the administration of medication, the time given, or errors such as giving the "wrong drug, dose, form, or not checking for allergies" and could affect the patient negatively. It has been reported that these errors have been reduced by "55-83%" because records are now online and require certain steps to avoid these errors.[14]

Electronic records may help with the standardization of forms, terminology, and data input.[15] Digitization of forms facilitates the collection of data for epidemiology and clinical studies.[16][17] However, standardization may create challenges for local practice.[9] Overall, those with EMRs that have automated notes and records, order entry, and clinical decision support had fewer complications, lower mortality rates, and lower costs.[18]

EMRs can be continuously updated (within certain legal limitations: see below). If the ability to exchange records between different EMR systems were perfected ("interoperability"[19]), it would facilitate the coordination of health care delivery in nonaffiliated health care facilities. In addition, data from an electronic system can be used anonymously for statistical reporting in matters such as quality improvement, resource management, and public health communicable disease surveillance.[20] However, it is difficult to remove data from its context.[9]

Usefulness for patients Edit

Sharing their electronic health records with people who have type 2 diabetes helps them to reduce their blood sugar levels. It is a way of helping people understand their own health condition and involving them actively in its management.[21][22][23]

They could also be useful in research, enabling various scientific analyses and novel tools (see below).

Use in research and development Edit

See also: Interoperability

Electronic medical records could also be studied to quantify disease burdens – such as the number of deaths from antimicrobial resistance[24] – or help identify causes of, factors of, links between[25][26] and contributors to diseases,[27][28][29] especially when combined with genome-wide association studies.[30][31]

This may enable increased flexibility, improved disease surveillance, better medical product safety surveillance,[32] better public health monitoring (such as for evaluation of health policy effectiveness),[33][34] increased quality of care (via guidelines[35] and improved medical history sharing[36][37]), and novel life-saving treatments.

Issues Edit

Privacy: For such purposes, electronic medical records could potentially be made available in securely anonymized or pseudonymized[38] forms to ensure patients' privacy is maintained[39][31][40][41] even if data breaches occur. There are concerns about the efficacy of some currently applied pseudonymization and data protection techniques, including the applied encryption.[42][36]

Documentation burden: While such records could enable avoiding duplication of work via records-sharing,[36][37] documentation burdens for medical facility personnel can be a further issue with EHRs. This burden could be reduced via voice recognition, optical character recognition, other technologies, involvement of physicians in changes to software, and other means[37][43][44][45] which could possibly reduce the documentation burden to below paper-based records documentation and low-level documentation.

Applications using software Edit

See also: Artificial intelligence in healthcare
 
GNU Health patient main screen as of 2013

Theoretically, free software such as GNU Health and other open source health software could be used or modified for various purposes that use electronic medical records i.a. via securely sharing anonymized patient treatments, medical history and individual outcomes (including by common primary care physicians).[46]

  • Decision-support: Electronic health records could also support clinical decision support systems.[47]
  • Personalized medicine: They could be used among other biodata for digital twins (also called health avatars) for personalized medicine.[48]
  • mHealth integration: They could be coupled with mHealth mobile applications and wearable technology.[47][37]
  • Screening: Artificial intelligence systems could use this data among other integrated data to screen for potential diseases via multimodal learning.[49]
  • Syndromic surveillance: Real-time analysis and data mining of the records could be used, along with other data, in syndromic surveillance to rapidly identify common exposures among patients suspected of being part of an outbreak, for epidemic forecasting,[50] and for early outbreak detection,[51][52][53][54] especially in identified potential pandemic pathogen (PPP) hotspot regions and potentially as a means for pandemic prevention.
  • Vaccination deployment: Interoperable, collaboratively developed, standardization-based health records systems could increase the speed of vaccination campaigns as well as reduce their costs or workloads. According to Dr. Bob Kocher, as of 2021 there are "1,000 different electronic health record systems in the U.S.,[globalize] and almost every hospital and clinic has a slightly different system tailored to its own needs" which caused difficulties and delays during COVID-19 vaccinations, with similar problems being reported in other countries.[55][56][37]
  • Medical outcomes data: Such records could also be used for matching patients to clinical trials with software,[57] generally reduce the burden on users to partake in research[37] and make previously siloed primary care data more valuable to society at larger or other patients.

Emergency medical services Edit

Ambulance services in Australia, the United States and the United Kingdom have introduced the use of EMR systems.[58][59] EMS Encounters in the United States are recorded using various platforms and vendors in compliance with the NEMSIS (National EMS Information System) standard.[60] The benefits of electronic records in ambulances include: patient data sharing, injury/illness prevention, better training for paramedics, review of clinical standards, better research options for pre-hospital care and design of future treatment options, data based outcome improvement, and clinical decision support.[61]

Technical features Edit

  • Digital formatting enables information to be used and shared over secure networks
  • Track care (e.g. prescriptions) and outcomes (e.g. blood pressure)
  • Trigger warnings and reminders
  • Send and receive orders, reports, and results
  • Decrease billing processing time and create more accurate billing system

Health Information Exchange[62]

  • Technical and social framework that enables information to move electronically between organizations

Using an EMR to read and write a patient's record is not only possible through a workstation but, depending on the type of system and health care settings, may also be possible through mobile devices that are handwriting capable,[63] tablets and smartphones. Electronic Medical Records may include access to Personal Health Records (PHR) which makes individual notes from an EMR readily visible and accessible for consumers.[citation needed]

Some EMR systems automatically monitor clinical events, by analyzing patient data from an electronic health record to predict, detect and potentially prevent adverse events. This can include discharge/transfer orders, pharmacy orders, radiology results, laboratory results and any other data from ancillary services or provider notes.[64] This type of event monitoring has been implemented using the Louisiana Public health information exchange linking statewide public health with electronic medical records. This system alerted medical providers when a patient with HIV/AIDS had not received care in over twelve months. This system greatly reduced the number of missed critical opportunities.[65]

Philosophical views Edit

Within a meta-narrative systematic review of research in the field, various different philosophical approaches to the EHR exist.[9] The health information systems literature has seen the EHR as a container holding information about the patient, and a tool for aggregating clinical data for secondary uses (billing, audit, etc.). However, other research traditions see the EHR as a contextualised artifact within a socio-technical system. For example, actor-network theory would see the EHR as an actant in a network,[66] and research in computer supported cooperative work (CSCW) sees the EHR as a tool supporting particular work.

Several possible advantages to EHRs over paper records have been proposed, but there is debate about the degree to which these are achieved in practice.[67]

Implementation Edit

Quality Edit

Several studies call into question whether EHRs improve the quality of care.[9][68][69][70][71] One 2011 study in diabetes care, published in the New England Journal of Medicine, found evidence that practices with EHR provided better quality care.[72]

EMRs may eventually help improve care coordination. An article in a trade journal suggests that since anyone using an EMR can view the patient's full chart, it cuts down on guessing histories, seeing multiple specialists, smooths transitions between care settings, and may allow better care in emergency situations.[73] EHRs may also improve prevention by providing doctors and patients better access to test results, identifying missing patient information, and offering evidence-based recommendations for preventive services.[74]

Costs Edit

The steep price and provider uncertainty regarding the value they will derive from adoption in the form of return on investment has a significant influence on EHR adoption.[75] In a project initiated by the Office of the National Coordinator for Health Information, surveyors found that hospital administrators and physicians who had adopted EHR noted that any gains in efficiency were offset by reduced productivity as the technology was implemented, as well as the need to increase information technology staff to maintain the system.[75]

The U.S. Congressional Budget Office concluded that the cost savings may occur only in large integrated institutions like Kaiser Permanente, and not in small physician offices. They challenged the Rand Corporation's estimates of savings. "Office-based physicians in particular may see no benefit if they purchase such a product—and may even suffer financial harm. Even though the use of health IT could generate cost savings for the health system at large that might offset the EHR's cost, many physicians might not be able to reduce their office expenses or increase their revenue sufficiently to pay for it. For example, the use of health IT could reduce the number of duplicated diagnostic tests. However, that improvement in efficiency would be unlikely to increase the income of many physicians."[76] One CEO of an EHR company has argued if a physician performs tests in the office, it might reduce his or her income.[77]

Doubts have been raised about cost saving from EHRs by researchers at Harvard University, the Wharton School of the University of Pennsylvania, Stanford University, and others.[71][78][79]

In 2022 the chief executive of Guy's and St Thomas' NHS Foundation Trust, one of the biggest NHS organisations, said that the £450 million cost over 15 years to install the Epic Systems electronic patient record across its six hospitals, which will reduce more than 100 different IT systems down to just a handful, was "chicken feed" when compared to the NHS's overall budget.[80]

Time Edit

The implementation of EMR can potentially decrease identification time of patients upon hospital admission. A research from the Annals of Internal Medicine showed that since the adoption of EMR a relative decrease in time by 65% has been recorded (from 130 to 46 hours).[81]

Software quality and usability deficiencies Edit

The Healthcare Information and Management Systems Society, a very large U.S. healthcare IT industry trade group, observed in 2009 that EHR adoption rates "have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available."[82][83] The U.S. National Institute of Standards and Technology of the Department of Commerce studied usability in 2011 and lists a number of specific issues that have been reported by health care workers.[84] The U.S. military's EHR, AHLTA, was reported to have significant usability issues.[85] Furthermore, studies such as the one conducted in BMC Medical Informatics and Decision Making, also showed that although the implementation of electronic medical records systems has been a great assistance to general practitioners there is still much room for revision in the overall framework and the amount of training provided.[86] It was observed that the efforts to improve EHR usability should be placed in the context of physician-patient communication.[87]

However, physicians are embracing mobile technologies such as smartphones and tablets at a rapid pace. According to a 2012 survey by Physicians Practice, 62.6 percent of respondents (1,369 physicians, practice managers, and other healthcare providers) say they use mobile devices in the performance of their job. Mobile devices are increasingly able to sync up with electronic health record systems thus allowing physicians to access patient records from remote locations. Most devices are extensions of desk-top EHR systems, using a variety of software to communicate and access files remotely. The advantages of instant access to patient records at any time and any place are clear, but bring a host of security concerns. As mobile systems become more prevalent, practices will need comprehensive policies that govern security measures and patient privacy regulations.[88]

Other advanced computational techniques have allowed EHRs to be evaluated at a much quicker rate. Natural language processing is increasingly used to search EMRs, especially through searching and analyzing notes and text that would otherwise be inaccessible for study when seeking to improve care.[89] One study found that several machine learning methods could be used to predict the rate of a patient's mortality with moderate success, with the most successful approach including using a combination of a convolutional neural network and a heterogenous graph model.[90]

Hardware and workflow considerations Edit

When a health facility has documented their workflow and chosen their software solution they must then consider the hardware and supporting device infrastructure for the end users. Staff and patients will need to engage with various devices throughout a patient's stay and charting workflow. Computers, laptops, all-in-one computers, tablets, mouse, keyboards and monitors are all hardware devices that may be utilized. Other considerations will include supporting work surfaces and equipment, wall desks or articulating arms for end users to work on. Another important factor is how all these devices will be physically secured and how they will be charged that staff can always utilize the devices for EHR charting when needed.

The success of eHealth interventions is largely dependent on the ability of the adopter to fully understand workflow and anticipate potential clinical processes prior to implementations. Failure to do so can create costly and time-consuming interruptions to service delivery.[91]

Unintended consequences Edit

Per empirical research in social informatics, information and communications technology (ICT) use can lead to both intended and unintended consequences.[92][93][94]

A 2008 Sentinel Event Alert from the U.S. Joint Commission, the organization that accredits American hospitals to provide healthcare services, states, 'As health information technology (HIT) and 'converging technologies'—the interrelationship between medical devices and HIT—are increasingly adopted by health care organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate. Technology-related adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission. These unintended adverse events typically stem from human-machine interfaces or organization/system design."[95] The Joint Commission cites as an example the United States Pharmacopeia MEDMARX database[96] where of 176,409 medication error records for 2006, approximately 25 percent (43,372) involved some aspect of computer technology as at least one cause of the error.

The British National Health Service (NHS) reports specific examples of potential and actual EHR-caused unintended consequences in its 2009 document on the management of clinical risk relating to the deployment and use of health software.[97]

In a February 2010, an American Food and Drug Administration (FDA) memorandum noted that EHR unintended consequences include EHR-related medical errors from (1) errors of commission (EOC), (2) errors of omission or transmission (EOT), (3) errors in data analysis (EDA), and (4) incompatibility between multi-vendor software applications or systems (ISMA), examples were cited. The FDA also noted that the "absence of mandatory reporting enforcement of H-IT safety issues limits the numbers of medical device reports (MDRs) and impedes a more comprehensive understanding of the actual problems and implications."[98][99]

A 2010 Board Position Paper by the American Medical Informatics Association (AMIA) contains recommendations on EHR-related patient safety, transparency, ethics education for purchasers and users, adoption of best practices, and re-examination of regulation of electronic health applications.[100] Beyond concrete issues such as conflicts of interest and privacy concerns, questions have been raised about the ways in which the physician-patient relationship would be affected by an electronic intermediary.[101][102]

During the implementation phase, cognitive workload for healthcare professionals may be significantly increased as they become familiar with a new system.[103]

EHRs are almost invariably detrimental to physician productivity, whether the data is entered during the encounter or sometime thereafter.[104] It is possible for an EHR to increase physician productivity [105] by providing a fast and intuitive interface for viewing and understanding patient clinical data and minimizing the number of clinically irrelevant questions,[citation needed] but that is almost never the case.[citation needed] The other way to mitigate the detriment to physician productivity is to hire scribes to work alongside medical practitioners, which is almost never financially viable.[citation needed]

As a result, many have conducted studies like the one discussed in the Journal of the American Medical Informatics Association, "The Extent And Importance of Unintended Consequences Related To Computerized Provider Order Entry," which seeks to understand the degree and significance of unplanned adverse consequences related to computerized physician order entry and understand how to interpret adverse events and understand the importance of its management for the overall success of computer physician order entry.[106]

Governance, privacy and legal issues Edit

Privacy concerns Edit

In the United States, Great Britain, and Germany, the concept of a national centralized server model of healthcare data has been poorly received.[107] Issues of privacy and security in such a model have been of concern.[108][109]

In the European Union (EU), a new directly binding instrument, a regulation of the European Parliament and of the council, was passed in 2016 to go into effect in 2018 to protect the processing of personal data, including that for purposes of health care, the General Data Protection Regulation.

Threats to health care information can be categorized under three headings:

  • Human threats, such as employees or hackers
  • Natural and environmental threats, such as earthquakes, hurricanes and fires.
  • Technology failures, such as a system crashing

These threats can either be internal, external, intentional and unintentional. Therefore, one will find health information systems professionals having these particular threats in mind when discussing ways to protect the health information of patients. It has been found that there is a lack of security awareness among health care professionals in countries such as Spain.[110] The Health Insurance Portability and Accountability Act (HIPAA) has developed a framework to mitigate the harm of these threats that is comprehensive but not so specific as to limit the options of healthcare professionals who may have access to different technology.[111] With the increase of clinical notes being shared electronically as a result of the 21st Century Cures Act, an increase in sensitive terms used across the records of all patients, including minors, are increasingly shared amongst care teams, complicating efforts to maintain privacy.[112]

Personal Information Protection and Electronic Documents Act (PIPEDA) was given Royal Assent in Canada on 13 April 2000 to establish rules on the use, disclosure and collection of personal information. The personal information includes both non-digital and electronic form. In 2002, PIPEDA extended to the health sector in Stage 2 of the law's implementation.[113] There are four provinces where this law does not apply because its privacy law was considered similar to PIPEDA: Alberta, British Columbia, Ontario and Quebec.

The COVID-19 pandemic in the United Kingdom led to radical changes. NHS Digital and NHSX made changes, said to be only for the duration of the crisis, to the information sharing system GP Connect across England, meaning that patient records are shared across primary care. Only patients who have specifically opted out are excluded.[114]

Legal issues Edit

Liability Edit

Legal liability in all aspects of healthcare was an increasing problem in the 1990s and 2000s. The surge in the per capita number of attorneys in the USA[115] and changes in the tort system caused an increase in the cost of every aspect of healthcare, and healthcare technology was no exception.[116]

Failure or damages caused during installation or utilization of an EHR system has been feared as a threat in lawsuits.[117] Similarly, it's important to recognize that the implementation of electronic health records carries with it significant legal risks.[118]

This liability concern was of special concern for small EHR system makers. Some smaller companies may be forced to abandon markets based on the regional liability climate.[119][unreliable source] Larger EHR providers (or government-sponsored providers of EHRs) are better able to withstand legal assaults.

While there is no argument that electronic documentation of patient visits and data brings improved patient care, there is increasing concern that such documentation could open physicians to an increased incidence of malpractice suits. Disabling physician alerts, selecting from dropdown menus, and the use of templates can encourage physicians to skip a complete review of past patient history and medications, and thus miss important data.

Another potential problem is electronic time stamps. Many physicians are unaware that EHR systems produce an electronic time stamp every time the patient record is updated. If a malpractice claim goes to court, through the process of discovery, the prosecution can request a detailed record of all entries made in a patient's electronic record. Waiting to chart patient notes until the end of the day and making addendums to records well after the patient visit can be problematic, in that this practice could result in less than accurate patient data or indicate possible intent to illegally alter the patient's record.[120]

In some communities, hospitals attempt to standardize EHR systems by providing discounted versions of the hospital's software to local healthcare providers. A challenge to this practice has been raised as being a violation of Stark rules that prohibit hospitals from preferentially assisting community healthcare providers.[121] In 2006, however, exceptions to the Stark rule were enacted to allow hospitals to furnish software and training to community providers, mostly removing this legal obstacle.[122][unreliable source][123][unreliable source]

Legal interoperability Edit

In cross-border use cases of EHR implementations, the additional issue of legal interoperability arises. Different countries may have diverging legal requirements for the content or usage of electronic health records, which can require radical changes to the technical makeup of the EHR implementation in question. (especially when fundamental legal incompatibilities are involved) Exploring these issues is therefore often necessary when implementing cross-border EHR solutions.[124]

Contribution under UN administration and accredited organizations Edit

The United Nations World Health Organization (WHO) administration intentionally does not contribute to an internationally standardized view of medical records nor to personal health records. However, WHO contributes to minimum requirements definition for developing countries.[125]

The United Nations accredited standardization body International Organization for Standardization (ISO) however has settled thorough word[clarification needed] for standards in the scope of the HL7 platform for health care informatics. Respective standards are available with ISO/HL7 10781:2009 Electronic Health Record-System Functional Model, Release 1.1[126] and subsequent set of detailing standards.[127]

Medical data breach Edit

The majority of the countries in Europe have made a strategy for the development and implementation of the Electronic Health Record Systems. This would mean greater access to health records by numerous stakeholders, even from countries with lower levels of privacy protection. The forthcoming implementation of the Cross Border Health Directive and the EU Commission's plans to centralize all health records are of prime concern to the EU public who believe that the health care organizations and governments cannot be trusted to manage their data electronically and expose them to more threats.

The idea of a centralized electronic health record system was poorly received by the public who are wary that governments may use of the system beyond its intended purpose. There is also the risk for privacy breaches that could allow sensitive health care information to fall into the wrong hands. Some countries have enacted laws requiring safeguards to be put in place to protect the security and confidentiality of medical information. These safeguards add protection for records that are shared electronically and give patients some important rights to monitor their medical records and receive notification for loss and unauthorized acquisition of health information. The United States and the EU have imposed mandatory medical data breach notifications.[128]

Breach notification Edit

The purpose of a personal data breach notification is to protect individuals so that they can take all the necessary actions to limit the undesirable effects of the breach and to motivate the organization to improve the security of the infrastructure to protect the confidentiality of the data. The US law requires the entities to inform the individuals in the event of breach while the EU Directive currently requires breach notification only when the breach is likely to adversely affect the privacy of the individual. Personal health data is valuable to individuals and is therefore difficult to make an assessment whether the breach will cause reputational or financial harm or cause adverse effects on one's privacy.

The Breach notification law in the EU provides better privacy safeguards with fewer exemptions, unlike the US law which exempts unintentional acquisition, access, or use of protected health information and inadvertent disclosure under a good faith belief.[128]

Technical issues Edit

Standards Edit

  • ASC X12 (EDI) – transaction protocols used for transmitting patient data. Popular in the United States for transmission of billing data.
  • CEN's TC/251 provides EHR standards in Europe including:
    • EN 13606, communication standards for EHR information
    • CONTSYS (EN 13940), supports continuity of care record standardization.
    • HISA (EN 12967), a services standard for inter-system communication in a clinical information environment.
  • Continuity of Care Record – ASTM International Continuity of Care Record standard
  • DICOM – an international communications protocol standard for representing and transmitting radiology (and other) image-based data, sponsored by NEMA (National Electrical Manufacturers Association)
  • HL7 (HL7v2, C-CDA) – a standardized messaging and text communications protocol between hospital and physician record systems, and between practice management systems
  • Fast Healthcare Interoperability Resources (FHIR) – a modernized proposal from HL7 designed to provide open, granular access to medical information
  • ISO – ISO TC 215 provides international technical specifications for EHRs. ISO 18308 describes EHR architectures
  • xDT – a family of data exchange formats for medical purposes that is used in the German public health system.

The U.S. federal government has issued new rules of electronic health records.[129]

Open specifications Edit

  • openEHR: an open community developed specification for a shared health record with web-based content developed online by experts. Strong multilingual capability.
  • Virtual Medical Record: HL7's proposed model for interfacing with clinical decision support systems.
  • SMART (Substitutable Medical Apps, reusable technologies): an open platform specification to provide a standard base for healthcare applications.[130]

Common data model (in health data context) Edit

A common data model (CDM) is a specification that describes how data from multiple sources (e.g., multiple EHR systems) can be combined. Many CDMs use a relational model (e.g., the OMOP CDM). A relational CDM defines names of tables and table columns and restricts what values are valid.

  • Sentinel Common Data Model: Initially started as Mini-Sentinel in 2008. Use by the Sentinel Initiative of the USA's Food and Drug Administration.
  • OMOP Common Data Model: model that defines how electronic health record data, medical billing data or other healthcare data from multiple institutions can be harmonized and queried in unified way. It is maintained by Observational Health Data Sciences and Informatics consortium.
  • PCORNet Common Data Model: First defined in 2014 and used by PCORI and People-Centered Research Foundation.
  • Virtual Data Warehouse: First defined in 2006 by HMO Research Network. Since 2015, by Health Care System Research Network.

Customization Edit

Each healthcare environment functions differently, often in significant ways. It is difficult to create a "one-size-fits-all" EHR system. Many first generation EHRs were designed to fit the needs of primary care physicians, leaving certain specialties significantly less satisfied with their EHR system.[citation needed]

An ideal EHR system will have record standardization but interfaces that can be customized to each provider environment. Modularity in an EHR system facilitates this. Many EHR companies employ vendors to provide customization.

This customization can often be done so that a physician's input interface closely mimics previously utilized paper forms.[131]

At the same time they reported negative effects in communication, increased overtime, and missing records when a non-customized EMR system was utilized.[132] Customizing the software when it is released yields the highest benefits because it is adapted for the users and tailored to workflows specific to the institution.[133]

Customization can have its disadvantages. There is, of course, higher costs involved to implementation of a customized system initially. More time must be spent by both the implementation team and the healthcare provider to understand the workflow needs.

Development and maintenance of these interfaces and customizations can also lead to higher software implementation and maintenance costs.[134][unreliable source][135][unreliable source]

Long-term preservation and storage of records Edit

An important consideration in the process of developing electronic health records is to plan for the long-term preservation and storage of these records. The field will need to come to consensus on the length of time to store EHRs, methods to ensure the future accessibility and compatibility of archived data with yet-to-be developed retrieval systems, and how to ensure the physical and virtual security of the archives.[citation needed]

Additionally, considerations about long-term storage of electronic health records are complicated by the possibility that the records might one day be used longitudinally and integrated across sites of care. Records have the potential to be created, used, edited, and viewed by multiple independent entities. These entities include, but are not limited to, primary care physicians, hospitals, insurance companies, and patients. Mandl et al. have noted that "choices about the structure and ownership of these records will have profound impact on the accessibility and privacy of patient information."[136]

The required length of storage of an individual electronic health record will depend on national and state regulations, which are subject to change over time.[137] Ruotsalainen and Manning have found that the typical preservation time of patient data varies between 20 and 100 years. In one example of how an EHR archive might function, their research "describes a co-operative trusted notary archive (TNA) which receives health data from different EHR-systems, stores data together with associated meta-information for long periods and distributes EHR-data objects. TNA can store objects in XML-format and prove the integrity of stored data with the help of event records, timestamps and archive e-signatures."[138]

In addition to the TNA archive described by Ruotsalainen and Manning, other combinations of EHR systems and archive systems are possible. Again, overall requirements for the design and security of the system and its archive will vary and must function under ethical and legal principles specific to the time and place.[citation needed]

While it is currently unknown precisely how long EHRs will be preserved, it is certain that length of time will exceed the average shelf-life of paper records. The evolution of technology is such that the programs and systems used to input information will likely not be available to a user who desires to examine archived data. One proposed solution to the challenge of long-term accessibility and usability of data by future systems is to standardize information fields in a time-invariant way, such as with XML language. Olhede and Peterson report that "the basic XML-format has undergone preliminary testing in Europe by a Spri project and been found suitable for EU purposes. Spri has advised the Swedish National Board of Health and Welfare and the Swedish National Archive to issue directives concerning the use of XML as the archive-format for EHCR (Electronic Health Care Record) information."[139]

Synchronization of records Edit

When care is provided at two different facilities, it may be difficult to update records at both locations in a co-ordinated fashion. Two models have been used to satisfy this problem: a centralized data server solution, and a peer-to-peer file synchronization program (as has been developed for other peer-to-peer networks). Synchronization programs for distributed storage models, however, are only useful once record standardization has occurred. Merging of already existing public healthcare databases is a common software challenge. The ability of electronic health record systems to provide this function is a key benefit and can improve healthcare delivery.[140][141][142]

eHealth and teleradiology Edit

The sharing of patient information between health care organizations and IT systems is changing from a "point to point" model to a "many to many" one. The European Commission is supporting moves to facilitate cross-border interoperability of e-health systems and to remove potential legal hurdles, as in the project www.epsos.eu/. To allow for global shared workflow, studies will be locked when they are being read and then unlocked and updated once reading is complete. Radiologists will be able to serve multiple health care facilities and read and report across large geographical areas, thus balancing workloads. The biggest challenges will relate to interoperability and legal clarity. In some countries it is almost forbidden to practice teleradiology. The variety of languages spoken is a problem and multilingual reporting templates for all anatomical regions are not yet available. However, the market for e-health and teleradiology is evolving more rapidly than any laws or regulations.[143]

Initiatives Edit

USA Edit

See Electronic health records in the United States

Russia Edit

In 2011, Moscow's government launched a major project known as UMIAS as part of its electronic healthcare initiative. UMIAS - the Unified Medical Information and Analytical System - connects more than 660 clinics and over 23,600 medical practitioners in Moscow. UMIAS covers 9.5 million patients, contains more than 359 million patient records and supports more than 500,000 different transactions daily. Approximately 700,000 Muscovites use remote links to make appointments every week.[144][145]

European Union Edit

The European Commission wants to boost the digital economy by enabling all Europeans to have access to online medical records anywhere in Europe by 2020. With the newly enacted Directive 2011/24/EU on patients' rights in cross-border healthcare due for implementation by 2013, it is inevitable that a centralised European health record system will become a reality even before 2020. However, the concept of a centralised supranational central server raises concern about storing electronic medical records in a central location. The privacy threat posed by a supranational network is a key concern. Cross-border and Interoperable electronic health record systems make confidential data more easily and rapidly accessible to a wider audience and increase the risk that personal data concerning health could be accidentally exposed or easily distributed to unauthorised parties by enabling greater access to a compilation of the personal data concerning health, from different sources, and throughout a lifetime.[146]

United Kingdom Edit

Further information: Electronic health records in England and Patient record access in the United Kingdom

The Lloyd George envelope digitisation project is the aim to have all paper copies of all historic patient data transferred onto computer systems. as part of the roll out new patients will no longer be given a transit label to register when moving practices. Not only is it a step closer to a Digital NHS and reduce the movement of records between practices, The Project also frees up space in practices that are used to store records as well as having the added benefit of being more environmentally friendly[147]

Lyniate was selected to provide data integration technologies for Health and Social Care (Northern Ireland) in 2022. Epic Systems will supply integrated electronic health records with a single digital record for every citizen. Lyniate Rhapsody, already used in used in 79 NHS Trusts, will be used to integrate the multiple health and social care systems.[148]

In veterinary medicine Edit

In UK veterinary practice, the replacement of paper recording systems with electronic methods of storing animal patient information escalated from the 1980s and the majority of clinics now use electronic medical records. In a sample of 129 veterinary practices, 89% used a Practice Management System (PMS) for data recording.[149] There are more than ten PMS providers currently in the UK. Collecting data directly from PMSs for epidemiological analysis abolishes the need for veterinarians to manually submit individual reports per animal visit and therefore increases the reporting rate.[150]

Veterinary electronic medical record data are being used to investigate antimicrobial efficacy; risk factors for canine cancer; and inherited diseases in dogs and cats, in the small animal disease surveillance project 'VetCOMPASS' (Veterinary Companion Animal Surveillance System) at the Royal Veterinary College, London, in collaboration with the University of Sydney (the VetCOMPASS project was formerly known as VEctAR).[151][152]

Turing test Edit

A letter published in Communications of the ACM[153] describes the concept of generating synthetic patient population and proposes a variation of Turing test to assess the difference between synthetic and real patients. The letter states: "In the EHR context, though a human physician can readily distinguish between synthetically generated and real live human patients, could a machine be given the intelligence to make such a determination on its own?" and further the letter states: "Before synthetic patient identities become a public health problem, the legitimate EHR market might benefit from applying Turing Test-like techniques to ensure greater data reliability and diagnostic value. Any new techniques must thus consider patients' heterogeneity and are likely to have greater complexity than the Allen eighth-grade-science-test is able to grade."[154]

See also Edit

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External links Edit

  • Open-Source EHR Systems for Ambulatory Care: A Market Assessment (California HealthCare Foundation, January 2008)
  • US Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC)
  • US Department of Health and Human Services (HHS), Agency for Healthcare Research and Quality (AHRQ), National Resource Center for Health Information Technology
  • Security Aspects in Electronic Personal Health Record: Data Access and Preservation – a briefing paper at Digital Preservation Europe

October 14, 2023
electronic, health, record, this, article, about, types, electronic, health, records, prescriptions, electronic, prescribing, electronic, health, record, systematized, collection, patient, population, electronically, stored, health, information, digital, forma. This article is about all types of electronic health records For prescriptions see Electronic prescribing An electronic health record EHR is the systematized collection of patient and population electronically stored health information in a digital format 1 These records can be shared across different health care settings Records are shared through network connected enterprise wide information systems or other information networks and exchanges EHRs may include a range of data including demographics medical history medication and allergies immunization status laboratory test results radiology images vital signs personal statistics like age and weight and billing information 2 Sample view of an electronic health recordFor several decades electronic health records EHRs have been touted as key to increasing of quality care 3 Electronic health records are used for other reasons than charting for patients 4 today providers are using data from patient records to improve quality outcomes through their care management programs EHR combines all patients demographics into a large pool and uses this information to assist with the creation of new treatments or innovation in healthcare delivery which overall improves the goals in healthcare 4 Combining multiple types of clinical data from the system s health records has helped clinicians identify and stratify chronically ill patients EHR can improve quality care by using the data and analytics to prevent hospitalizations among high risk patients EHR systems are designed to store data accurately and to capture the state of a patient across time It eliminates the need to track down a patient s previous paper medical records and assists in ensuring data is up to date 5 accurate and legible It also allows open communication between the patient and the provider while providing privacy and security 5 It can reduce risk of data replication as there is only one modifiable file which means the file is more likely up to date and decreases risk of lost paperwork and is cost efficient 5 Due to the digital information being searchable and in a single file EMRs electronic medical records are more effective when extracting medical data for the examination of possible trends and long term changes in a patient Population based studies of medical records may also be facilitated by the widespread adoption of EHRs and EMRs Contents 1 Terminology 2 Comparison with paper based records 2 1 Usefulness for patients 3 Use in research and development 3 1 Issues 3 2 Applications using software 4 Emergency medical services 5 Technical features 6 Philosophical views 7 Implementation 7 1 Quality 7 2 Costs 7 3 Time 7 4 Software quality and usability deficiencies 7 5 Hardware and workflow considerations 7 6 Unintended consequences 8 Governance privacy and legal issues 8 1 Privacy concerns 8 2 Legal issues 8 2 1 Liability 8 2 2 Legal interoperability 9 Contribution under UN administration and accredited organizations 10 Medical data breach 10 1 Breach notification 11 Technical issues 11 1 Standards 11 1 1 Open specifications 11 1 2 Common data model in health data context 11 1 3 Customization 11 2 Long term preservation and storage of records 11 3 Synchronization of records 12 eHealth and teleradiology 13 Initiatives 13 1 USA 13 2 Russia 13 3 European Union 13 4 United Kingdom 13 5 In veterinary medicine 14 Turing test 15 See also 16 References 17 External linksTerminology EditThe terms EHR electronic patient record EPR and EMR have often been used interchangeably but differences between the models are now being defined The electronic health record EHR is a more longitudinal collection of the electronic health information of individual patients or populations The EMR in contrast is the patient record created by providers for specific encounters in hospitals and ambulatory environments and can serve as a data source for an EHR 6 7 In contrast a personal health record PHR is an electronic application for recording personal medical data that the individual patient controls and may make available to health providers 8 Comparison with paper based records EditWhile there is still a considerable amount of debate around the superiority of electronic health records over paper records the research literature paints a more realistic picture of the benefits and downsides 9 The increased transparency portability and accessibility acquired by the adoption of electronic medical records may increase the ease with which they can be accessed by healthcare professionals but also can increase the amount of stolen information by unauthorized persons or unscrupulous users versus paper medical records as acknowledged by the increased security requirements for electronic medical records included in the Health Information and Accessibility Act and by large scale breaches in confidential records reported by EMR users 10 11 Concerns about security contribute to the resistance shown to their adoption weasel words When users log in into the electronic health records it is their responsibility to make sure the information stays confidential and this is done by keeping their passwords unknown to others and logging off before leaving the station 12 Handwritten paper medical records may be poorly legible which can contribute to medical errors 13 Pre printed forms standardization of abbreviations and standards for penmanship were encouraged to improve the reliability of paper medical records An example of possible medical errors is the administration of medication Medication is an intervention that can turn a person s status from stable to unstable very quickly With paper documentation it is very easy to not properly document the administration of medication the time given or errors such as giving the wrong drug dose form or not checking for allergies and could affect the patient negatively It has been reported that these errors have been reduced by 55 83 because records are now online and require certain steps to avoid these errors 14 Electronic records may help with the standardization of forms terminology and data input 15 Digitization of forms facilitates the collection of data for epidemiology and clinical studies 16 17 However standardization may create challenges for local practice 9 Overall those with EMRs that have automated notes and records order entry and clinical decision support had fewer complications lower mortality rates and lower costs 18 EMRs can be continuously updated within certain legal limitations see below If the ability to exchange records between different EMR systems were perfected interoperability 19 it would facilitate the coordination of health care delivery in nonaffiliated health care facilities In addition data from an electronic system can be used anonymously for statistical reporting in matters such as quality improvement resource management and public health communicable disease surveillance 20 However it is difficult to remove data from its context 9 Usefulness for patients Edit Sharing their electronic health records with people who have type 2 diabetes helps them to reduce their blood sugar levels It is a way of helping people understand their own health condition and involving them actively in its management 21 22 23 They could also be useful in research enabling various scientific analyses and novel tools see below Use in research and development EditSee also Interoperability Electronic medical records could also be studied to quantify disease burdens such as the number of deaths from antimicrobial resistance 24 or help identify causes of factors of links between 25 26 and contributors to diseases 27 28 29 especially when combined with genome wide association studies 30 31 This may enable increased flexibility improved disease surveillance better medical product safety surveillance 32 better public health monitoring such as for evaluation of health policy effectiveness 33 34 increased quality of care via guidelines 35 and improved medical history sharing 36 37 and novel life saving treatments Issues Edit Privacy For such purposes electronic medical records could potentially be made available in securely anonymized or pseudonymized 38 forms to ensure patients privacy is maintained 39 31 40 41 even if data breaches occur There are concerns about the efficacy of some currently applied pseudonymization and data protection techniques including the applied encryption 42 36 Documentation burden While such records could enable avoiding duplication of work via records sharing 36 37 documentation burdens for medical facility personnel can be a further issue with EHRs This burden could be reduced via voice recognition optical character recognition other technologies involvement of physicians in changes to software and other means 37 43 44 45 which could possibly reduce the documentation burden to below paper based records documentation and low level documentation Applications using software Edit See also Artificial intelligence in healthcare nbsp GNU Health patient main screen as of 2013Theoretically free software such as GNU Health and other open source health software could be used or modified for various purposes that use electronic medical records i a via securely sharing anonymized patient treatments medical history and individual outcomes including by common primary care physicians 46 Decision support Electronic health records could also support clinical decision support systems 47 Personalized medicine They could be used among other biodata for digital twins also called health avatars for personalized medicine 48 mHealth integration They could be coupled with mHealth mobile applications and wearable technology 47 37 Screening Artificial intelligence systems could use this data among other integrated data to screen for potential diseases via multimodal learning 49 Syndromic surveillance Real time analysis and data mining of the records could be used along with other data in syndromic surveillance to rapidly identify common exposures among patients suspected of being part of an outbreak for epidemic forecasting 50 and for early outbreak detection 51 52 53 54 especially in identified potential pandemic pathogen PPP hotspot regions and potentially as a means for pandemic prevention Vaccination deployment Interoperable collaboratively developed standardization based health records systems could increase the speed of vaccination campaigns as well as reduce their costs or workloads According to Dr Bob Kocher as of 2021 there are 1 000 different electronic health record systems in the U S globalize and almost every hospital and clinic has a slightly different system tailored to its own needs which caused difficulties and delays during COVID 19 vaccinations with similar problems being reported in other countries 55 56 37 Medical outcomes data Such records could also be used for matching patients to clinical trials with software 57 generally reduce the burden on users to partake in research 37 and make previously siloed primary care data more valuable to society at larger or other patients Emergency medical services EditAmbulance services in Australia the United States and the United Kingdom have introduced the use of EMR systems 58 59 EMS Encounters in the United States are recorded using various platforms and vendors in compliance with the NEMSIS National EMS Information System standard 60 The benefits of electronic records in ambulances include patient data sharing injury illness prevention better training for paramedics review of clinical standards better research options for pre hospital care and design of future treatment options data based outcome improvement and clinical decision support 61 Technical features EditDigital formatting enables information to be used and shared over secure networks Track care e g prescriptions and outcomes e g blood pressure Trigger warnings and reminders Send and receive orders reports and results Decrease billing processing time and create more accurate billing systemHealth Information Exchange 62 Technical and social framework that enables information to move electronically between organizationsUsing an EMR to read and write a patient s record is not only possible through a workstation but depending on the type of system and health care settings may also be possible through mobile devices that are handwriting capable 63 tablets and smartphones Electronic Medical Records may include access to Personal Health Records PHR which makes individual notes from an EMR readily visible and accessible for consumers citation needed Some EMR systems automatically monitor clinical events by analyzing patient data from an electronic health record to predict detect and potentially prevent adverse events This can include discharge transfer orders pharmacy orders radiology results laboratory results and any other data from ancillary services or provider notes 64 This type of event monitoring has been implemented using the Louisiana Public health information exchange linking statewide public health with electronic medical records This system alerted medical providers when a patient with HIV AIDS had not received care in over twelve months This system greatly reduced the number of missed critical opportunities 65 Philosophical views EditWithin a meta narrative systematic review of research in the field various different philosophical approaches to the EHR exist 9 The health information systems literature has seen the EHR as a container holding information about the patient and a tool for aggregating clinical data for secondary uses billing audit etc However other research traditions see the EHR as a contextualised artifact within a socio technical system For example actor network theory would see the EHR as an actant in a network 66 and research in computer supported cooperative work CSCW sees the EHR as a tool supporting particular work Several possible advantages to EHRs over paper records have been proposed but there is debate about the degree to which these are achieved in practice 67 Implementation EditQuality Edit Several studies call into question whether EHRs improve the quality of care 9 68 69 70 71 One 2011 study in diabetes care published in the New England Journal of Medicine found evidence that practices with EHR provided better quality care 72 EMRs may eventually help improve care coordination An article in a trade journal suggests that since anyone using an EMR can view the patient s full chart it cuts down on guessing histories seeing multiple specialists smooths transitions between care settings and may allow better care in emergency situations 73 EHRs may also improve prevention by providing doctors and patients better access to test results identifying missing patient information and offering evidence based recommendations for preventive services 74 Costs Edit The steep price and provider uncertainty regarding the value they will derive from adoption in the form of return on investment has a significant influence on EHR adoption 75 In a project initiated by the Office of the National Coordinator for Health Information surveyors found that hospital administrators and physicians who had adopted EHR noted that any gains in efficiency were offset by reduced productivity as the technology was implemented as well as the need to increase information technology staff to maintain the system 75 The U S Congressional Budget Office concluded that the cost savings may occur only in large integrated institutions like Kaiser Permanente and not in small physician offices They challenged the Rand Corporation s estimates of savings Office based physicians in particular may see no benefit if they purchase such a product and may even suffer financial harm Even though the use of health IT could generate cost savings for the health system at large that might offset the EHR s cost many physicians might not be able to reduce their office expenses or increase their revenue sufficiently to pay for it For example the use of health IT could reduce the number of duplicated diagnostic tests However that improvement in efficiency would be unlikely to increase the income of many physicians 76 One CEO of an EHR company has argued if a physician performs tests in the office it might reduce his or her income 77 Doubts have been raised about cost saving from EHRs by researchers at Harvard University the Wharton School of the University of Pennsylvania Stanford University and others 71 78 79 In 2022 the chief executive of Guy s and St Thomas NHS Foundation Trust one of the biggest NHS organisations said that the 450 million cost over 15 years to install the Epic Systems electronic patient record across its six hospitals which will reduce more than 100 different IT systems down to just a handful was chicken feed when compared to the NHS s overall budget 80 Time Edit The implementation of EMR can potentially decrease identification time of patients upon hospital admission A research from the Annals of Internal Medicine showed that since the adoption of EMR a relative decrease in time by 65 has been recorded from 130 to 46 hours 81 Software quality and usability deficiencies Edit The Healthcare Information and Management Systems Society a very large U S healthcare IT industry trade group observed in 2009 that EHR adoption rates have been slower than expected in the United States especially in comparison to other industry sectors and other developed countries A key reason aside from initial costs and lost productivity during EMR implementation is lack of efficiency and usability of EMRs currently available 82 83 The U S National Institute of Standards and Technology of the Department of Commerce studied usability in 2011 and lists a number of specific issues that have been reported by health care workers 84 The U S military s EHR AHLTA was reported to have significant usability issues 85 Furthermore studies such as the one conducted in BMC Medical Informatics and Decision Making also showed that although the implementation of electronic medical records systems has been a great assistance to general practitioners there is still much room for revision in the overall framework and the amount of training provided 86 It was observed that the efforts to improve EHR usability should be placed in the context of physician patient communication 87 However physicians are embracing mobile technologies such as smartphones and tablets at a rapid pace According to a 2012 survey by Physicians Practice 62 6 percent of respondents 1 369 physicians practice managers and other healthcare providers say they use mobile devices in the performance of their job Mobile devices are increasingly able to sync up with electronic health record systems thus allowing physicians to access patient records from remote locations Most devices are extensions of desk top EHR systems using a variety of software to communicate and access files remotely The advantages of instant access to patient records at any time and any place are clear but bring a host of security concerns As mobile systems become more prevalent practices will need comprehensive policies that govern security measures and patient privacy regulations 88 Other advanced computational techniques have allowed EHRs to be evaluated at a much quicker rate Natural language processing is increasingly used to search EMRs especially through searching and analyzing notes and text that would otherwise be inaccessible for study when seeking to improve care 89 One study found that several machine learning methods could be used to predict the rate of a patient s mortality with moderate success with the most successful approach including using a combination of a convolutional neural network and a heterogenous graph model 90 Hardware and workflow considerations Edit When a health facility has documented their workflow and chosen their software solution they must then consider the hardware and supporting device infrastructure for the end users Staff and patients will need to engage with various devices throughout a patient s stay and charting workflow Computers laptops all in one computers tablets mouse keyboards and monitors are all hardware devices that may be utilized Other considerations will include supporting work surfaces and equipment wall desks or articulating arms for end users to work on Another important factor is how all these devices will be physically secured and how they will be charged that staff can always utilize the devices for EHR charting when needed The success of eHealth interventions is largely dependent on the ability of the adopter to fully understand workflow and anticipate potential clinical processes prior to implementations Failure to do so can create costly and time consuming interruptions to service delivery 91 Unintended consequences Edit Per empirical research in social informatics information and communications technology ICT use can lead to both intended and unintended consequences 92 93 94 A 2008 Sentinel Event Alert from the U S Joint Commission the organization that accredits American hospitals to provide healthcare services states As health information technology HIT and converging technologies the interrelationship between medical devices and HIT are increasingly adopted by health care organizations users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate Technology related adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission These unintended adverse events typically stem from human machine interfaces or organization system design 95 The Joint Commission cites as an example the United States Pharmacopeia MEDMARX database 96 where of 176 409 medication error records for 2006 approximately 25 percent 43 372 involved some aspect of computer technology as at least one cause of the error The British National Health Service NHS reports specific examples of potential and actual EHR caused unintended consequences in its 2009 document on the management of clinical risk relating to the deployment and use of health software 97 In a February 2010 an American Food and Drug Administration FDA memorandum noted that EHR unintended consequences include EHR related medical errors from 1 errors of commission EOC 2 errors of omission or transmission EOT 3 errors in data analysis EDA and 4 incompatibility between multi vendor software applications or systems ISMA examples were cited The FDA also noted that the absence of mandatory reporting enforcement of H IT safety issues limits the numbers of medical device reports MDRs and impedes a more comprehensive understanding of the actual problems and implications 98 99 A 2010 Board Position Paper by the American Medical Informatics Association AMIA contains recommendations on EHR related patient safety transparency ethics education for purchasers and users adoption of best practices and re examination of regulation of electronic health applications 100 Beyond concrete issues such as conflicts of interest and privacy concerns questions have been raised about the ways in which the physician patient relationship would be affected by an electronic intermediary 101 102 During the implementation phase cognitive workload for healthcare professionals may be significantly increased as they become familiar with a new system 103 EHRs are almost invariably detrimental to physician productivity whether the data is entered during the encounter or sometime thereafter 104 It is possible for an EHR to increase physician productivity 105 by providing a fast and intuitive interface for viewing and understanding patient clinical data and minimizing the number of clinically irrelevant questions citation needed but that is almost never the case citation needed The other way to mitigate the detriment to physician productivity is to hire scribes to work alongside medical practitioners which is almost never financially viable citation needed As a result many have conducted studies like the one discussed in the Journal of the American Medical Informatics Association The Extent And Importance of Unintended Consequences Related To Computerized Provider Order Entry which seeks to understand the degree and significance of unplanned adverse consequences related to computerized physician order entry and understand how to interpret adverse events and understand the importance of its management for the overall success of computer physician order entry 106 Governance privacy and legal issues EditPrivacy concerns Edit In the United States Great Britain and Germany the concept of a national centralized server model of healthcare data has been poorly received 107 Issues of privacy and security in such a model have been of concern 108 109 In the European Union EU a new directly binding instrument a regulation of the European Parliament and of the council was passed in 2016 to go into effect in 2018 to protect the processing of personal data including that for purposes of health care the General Data Protection Regulation Threats to health care information can be categorized under three headings Human threats such as employees or hackers Natural and environmental threats such as earthquakes hurricanes and fires Technology failures such as a system crashingThese threats can either be internal external intentional and unintentional Therefore one will find health information systems professionals having these particular threats in mind when discussing ways to protect the health information of patients It has been found that there is a lack of security awareness among health care professionals in countries such as Spain 110 The Health Insurance Portability and Accountability Act HIPAA has developed a framework to mitigate the harm of these threats that is comprehensive but not so specific as to limit the options of healthcare professionals who may have access to different technology 111 With the increase of clinical notes being shared electronically as a result of the 21st Century Cures Act an increase in sensitive terms used across the records of all patients including minors are increasingly shared amongst care teams complicating efforts to maintain privacy 112 Personal Information Protection and Electronic Documents Act PIPEDA was given Royal Assent in Canada on 13 April 2000 to establish rules on the use disclosure and collection of personal information The personal information includes both non digital and electronic form In 2002 PIPEDA extended to the health sector in Stage 2 of the law s implementation 113 There are four provinces where this law does not apply because its privacy law was considered similar to PIPEDA Alberta British Columbia Ontario and Quebec The COVID 19 pandemic in the United Kingdom led to radical changes NHS Digital and NHSX made changes said to be only for the duration of the crisis to the information sharing system GP Connect across England meaning that patient records are shared across primary care Only patients who have specifically opted out are excluded 114 Legal issues Edit Liability Edit Legal liability in all aspects of healthcare was an increasing problem in the 1990s and 2000s The surge in the per capita number of attorneys in the USA 115 and changes in the tort system caused an increase in the cost of every aspect of healthcare and healthcare technology was no exception 116 Failure or damages caused during installation or utilization of an EHR system has been feared as a threat in lawsuits 117 Similarly it s important to recognize that the implementation of electronic health records carries with it significant legal risks 118 This liability concern was of special concern for small EHR system makers Some smaller companies may be forced to abandon markets based on the regional liability climate 119 unreliable source Larger EHR providers or government sponsored providers of EHRs are better able to withstand legal assaults While there is no argument that electronic documentation of patient visits and data brings improved patient care there is increasing concern that such documentation could open physicians to an increased incidence of malpractice suits Disabling physician alerts selecting from dropdown menus and the use of templates can encourage physicians to skip a complete review of past patient history and medications and thus miss important data Another potential problem is electronic time stamps Many physicians are unaware that EHR systems produce an electronic time stamp every time the patient record is updated If a malpractice claim goes to court through the process of discovery the prosecution can request a detailed record of all entries made in a patient s electronic record Waiting to chart patient notes until the end of the day and making addendums to records well after the patient visit can be problematic in that this practice could result in less than accurate patient data or indicate possible intent to illegally alter the patient s record 120 In some communities hospitals attempt to standardize EHR systems by providing discounted versions of the hospital s software to local healthcare providers A challenge to this practice has been raised as being a violation of Stark rules that prohibit hospitals from preferentially assisting community healthcare providers 121 In 2006 however exceptions to the Stark rule were enacted to allow hospitals to furnish software and training to community providers mostly removing this legal obstacle 122 unreliable source 123 unreliable source Legal interoperability Edit In cross border use cases of EHR implementations the additional issue of legal interoperability arises Different countries may have diverging legal requirements for the content or usage of electronic health records which can require radical changes to the technical makeup of the EHR implementation in question especially when fundamental legal incompatibilities are involved Exploring these issues is therefore often necessary when implementing cross border EHR solutions 124 Contribution under UN administration and accredited organizations EditThe United Nations World Health Organization WHO administration intentionally does not contribute to an internationally standardized view of medical records nor to personal health records However WHO contributes to minimum requirements definition for developing countries 125 The United Nations accredited standardization body International Organization for Standardization ISO however has settled thorough word clarification needed for standards in the scope of the HL7 platform for health care informatics Respective standards are available with ISO HL7 10781 2009 Electronic Health Record System Functional Model Release 1 1 126 and subsequent set of detailing standards 127 Medical data breach EditThe majority of the countries in Europe have made a strategy for the development and implementation of the Electronic Health Record Systems This would mean greater access to health records by numerous stakeholders even from countries with lower levels of privacy protection The forthcoming implementation of the Cross Border Health Directive and the EU Commission s plans to centralize all health records are of prime concern to the EU public who believe that the health care organizations and governments cannot be trusted to manage their data electronically and expose them to more threats The idea of a centralized electronic health record system was poorly received by the public who are wary that governments may use of the system beyond its intended purpose There is also the risk for privacy breaches that could allow sensitive health care information to fall into the wrong hands Some countries have enacted laws requiring safeguards to be put in place to protect the security and confidentiality of medical information These safeguards add protection for records that are shared electronically and give patients some important rights to monitor their medical records and receive notification for loss and unauthorized acquisition of health information The United States and the EU have imposed mandatory medical data breach notifications 128 Breach notification Edit The purpose of a personal data breach notification is to protect individuals so that they can take all the necessary actions to limit the undesirable effects of the breach and to motivate the organization to improve the security of the infrastructure to protect the confidentiality of the data The US law requires the entities to inform the individuals in the event of breach while the EU Directive currently requires breach notification only when the breach is likely to adversely affect the privacy of the individual Personal health data is valuable to individuals and is therefore difficult to make an assessment whether the breach will cause reputational or financial harm or cause adverse effects on one s privacy The Breach notification law in the EU provides better privacy safeguards with fewer exemptions unlike the US law which exempts unintentional acquisition access or use of protected health information and inadvertent disclosure under a good faith belief 128 Technical issues EditStandards Edit ASC X12 EDI transaction protocols used for transmitting patient data Popular in the United States for transmission of billing data CEN s TC 251 provides EHR standards in Europe including EN 13606 communication standards for EHR information CONTSYS EN 13940 supports continuity of care record standardization HISA EN 12967 a services standard for inter system communication in a clinical information environment Continuity of Care Record ASTM International Continuity of Care Record standard DICOM an international communications protocol standard for representing and transmitting radiology and other image based data sponsored by NEMA National Electrical Manufacturers Association HL7 HL7v2 C CDA a standardized messaging and text communications protocol between hospital and physician record systems and between practice management systems Fast Healthcare Interoperability Resources FHIR a modernized proposal from HL7 designed to provide open granular access to medical information ISO ISO TC 215 provides international technical specifications for EHRs ISO 18308 describes EHR architectures xDT a family of data exchange formats for medical purposes that is used in the German public health system The U S federal government has issued new rules of electronic health records 129 Open specifications Edit openEHR an open community developed specification for a shared health record with web based content developed online by experts Strong multilingual capability Virtual Medical Record HL7 s proposed model for interfacing with clinical decision support systems SMART Substitutable Medical Apps reusable technologies an open platform specification to provide a standard base for healthcare applications 130 Common data model in health data context Edit A common data model CDM is a specification that describes how data from multiple sources e g multiple EHR systems can be combined Many CDMs use a relational model e g the OMOP CDM A relational CDM defines names of tables and table columns and restricts what values are valid Sentinel Common Data Model Initially started as Mini Sentinel in 2008 Use by the Sentinel Initiative of the USA s Food and Drug Administration OMOP Common Data Model model that defines how electronic health record data medical billing data or other healthcare data from multiple institutions can be harmonized and queried in unified way It is maintained by Observational Health Data Sciences and Informatics consortium PCORNet Common Data Model First defined in 2014 and used by PCORI and People Centered Research Foundation Virtual Data Warehouse First defined in 2006 by HMO Research Network Since 2015 by Health Care System Research Network Customization Edit Each healthcare environment functions differently often in significant ways It is difficult to create a one size fits all EHR system Many first generation EHRs were designed to fit the needs of primary care physicians leaving certain specialties significantly less satisfied with their EHR system citation needed An ideal EHR system will have record standardization but interfaces that can be customized to each provider environment Modularity in an EHR system facilitates this Many EHR companies employ vendors to provide customization This customization can often be done so that a physician s input interface closely mimics previously utilized paper forms 131 At the same time they reported negative effects in communication increased overtime and missing records when a non customized EMR system was utilized 132 Customizing the software when it is released yields the highest benefits because it is adapted for the users and tailored to workflows specific to the institution 133 Customization can have its disadvantages There is of course higher costs involved to implementation of a customized system initially More time must be spent by both the implementation team and the healthcare provider to understand the workflow needs Development and maintenance of these interfaces and customizations can also lead to higher software implementation and maintenance costs 134 unreliable source 135 unreliable source Long term preservation and storage of records Edit An important consideration in the process of developing electronic health records is to plan for the long term preservation and storage of these records The field will need to come to consensus on the length of time to store EHRs methods to ensure the future accessibility and compatibility of archived data with yet to be developed retrieval systems and how to ensure the physical and virtual security of the archives citation needed Additionally considerations about long term storage of electronic health records are complicated by the possibility that the records might one day be used longitudinally and integrated across sites of care Records have the potential to be created used edited and viewed by multiple independent entities These entities include but are not limited to primary care physicians hospitals insurance companies and patients Mandl et al have noted that choices about the structure and ownership of these records will have profound impact on the accessibility and privacy of patient information 136 The required length of storage of an individual electronic health record will depend on national and state regulations which are subject to change over time 137 Ruotsalainen and Manning have found that the typical preservation time of patient data varies between 20 and 100 years In one example of how an EHR archive might function their research describes a co operative trusted notary archive TNA which receives health data from different EHR systems stores data together with associated meta information for long periods and distributes EHR data objects TNA can store objects in XML format and prove the integrity of stored data with the help of event records timestamps and archive e signatures 138 In addition to the TNA archive described by Ruotsalainen and Manning other combinations of EHR systems and archive systems are possible Again overall requirements for the design and security of the system and its archive will vary and must function under ethical and legal principles specific to the time and place citation needed While it is currently unknown precisely how long EHRs will be preserved it is certain that length of time will exceed the average shelf life of paper records The evolution of technology is such that the programs and systems used to input information will likely not be available to a user who desires to examine archived data One proposed solution to the challenge of long term accessibility and usability of data by future systems is to standardize information fields in a time invariant way such as with XML language Olhede and Peterson report that the basic XML format has undergone preliminary testing in Europe by a Spri project and been found suitable for EU purposes Spri has advised the Swedish National Board of Health and Welfare and the Swedish National Archive to issue directives concerning the use of XML as the archive format for EHCR Electronic Health Care Record information 139 Synchronization of records Edit When care is provided at two different facilities it may be difficult to update records at both locations in a co ordinated fashion Two models have been used to satisfy this problem a centralized data server solution and a peer to peer file synchronization program as has been developed for other peer to peer networks Synchronization programs for distributed storage models however are only useful once record standardization has occurred Merging of already existing public healthcare databases is a common software challenge The ability of electronic health record systems to provide this function is a key benefit and can improve healthcare delivery 140 141 142 eHealth and teleradiology EditThe sharing of patient information between health care organizations and IT systems is changing from a point to point model to a many to many one The European Commission is supporting moves to facilitate cross border interoperability of e health systems and to remove potential legal hurdles as in the project www epsos eu To allow for global shared workflow studies will be locked when they are being read and then unlocked and updated once reading is complete Radiologists will be able to serve multiple health care facilities and read and report across large geographical areas thus balancing workloads The biggest challenges will relate to interoperability and legal clarity In some countries it is almost forbidden to practice teleradiology The variety of languages spoken is a problem and multilingual reporting templates for all anatomical regions are not yet available However the market for e health and teleradiology is evolving more rapidly than any laws or regulations 143 Initiatives EditUSA Edit See Electronic health records in the United States Russia Edit In 2011 Moscow s government launched a major project known as UMIAS as part of its electronic healthcare initiative UMIAS the Unified Medical Information and Analytical System connects more than 660 clinics and over 23 600 medical practitioners in Moscow UMIAS covers 9 5 million patients contains more than 359 million patient records and supports more than 500 000 different transactions daily Approximately 700 000 Muscovites use remote links to make appointments every week 144 145 European Union Edit The European Commission wants to boost the digital economy by enabling all Europeans to have access to online medical records anywhere in Europe by 2020 With the newly enacted Directive 2011 24 EU on patients rights in cross border healthcare due for implementation by 2013 it is inevitable that a centralised European health record system will become a reality even before 2020 However the concept of a centralised supranational central server raises concern about storing electronic medical records in a central location The privacy threat posed by a supranational network is a key concern Cross border and Interoperable electronic health record systems make confidential data more easily and rapidly accessible to a wider audience and increase the risk that personal data concerning health could be accidentally exposed or easily distributed to unauthorised parties by enabling greater access to a compilation of the personal data concerning health from different sources and throughout a lifetime 146 United Kingdom Edit Further information Electronic health records in England and Patient record access in the United KingdomThe Lloyd George envelope digitisation project is the aim to have all paper copies of all historic patient data transferred onto computer systems as part of the roll out new patients will no longer be given a transit label to register when moving practices Not only is it a step closer to a Digital NHS and reduce the movement of records between practices The Project also frees up space in practices that are used to store records as well as having the added benefit of being more environmentally friendly 147 Lyniate was selected to provide data integration technologies for Health and Social Care Northern Ireland in 2022 Epic Systems will supply integrated electronic health records with a single digital record for every citizen Lyniate Rhapsody already used in used in 79 NHS Trusts will be used to integrate the multiple health and social care systems 148 In veterinary medicine Edit In UK veterinary practice the replacement of paper recording systems with electronic methods of storing animal patient information escalated from the 1980s and the majority of clinics now use electronic medical records In a sample of 129 veterinary practices 89 used a Practice Management System PMS for data recording 149 There are more than ten PMS providers currently in the UK Collecting data directly from PMSs for epidemiological analysis abolishes the need for veterinarians to manually submit individual reports per animal visit and therefore increases the reporting rate 150 Veterinary electronic medical record data are being used to investigate antimicrobial efficacy risk factors for canine cancer and inherited diseases in dogs and cats in the small animal disease surveillance project VetCOMPASS Veterinary Companion Animal Surveillance System at the Royal Veterinary College London in collaboration with the University of Sydney the VetCOMPASS project was formerly known as VEctAR 151 152 Turing test EditA letter published in Communications of the ACM 153 describes the concept of generating synthetic patient population and 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