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== Regulatory compliance ==
== Regulatory compliance ==
* [[HIPAA]]
* [[Health Level 7]]
* [[Title 21 CFR Part 11]]
{{Expand-section|date=9 april 2010}}
{{Expand-section|date=9 april 2010}}



Revision as of 10:10, 9 April 2010


An electronic medical record is usually a computerized legal medical record created in an organization that delivers care, such as a hospital and doctor's surgery.[1] Electronic medical records tend to be a part of a local stand-alone health information system that allows storage, retrieval and manipulation of records.

Contrast with paper-based record

Paper-based records require a significant amount of storage space compared to digital records. In the US, most states require physical records be held for a minimum of seven years. The costs of storage media, such as paper and film, per unit of information differ dramatically from that of electronic storage media. When paper records are stored in different locations, collating them to a single location for review by a healthcare provider is time consuming and complicated, whereas the process can be simplified with electronic records. This is particularly true in the case of person-centred records, which are impractical to maintain if not electronic (thus difficult to centralise or federate). When paper-based records are required in multiple locations, copying, faxing, and transporting costs are significant compared to duplication and transfer of digital records.[citation needed].

One study estimates electronic medical records improve efficiency by 6% per year, and the monthly cost of an EMR is offset by the cost of only a few unnecessary tests or admissions.[2][3] Jerome Groopman disputed these results, publicly asking "how such dramatic claims of cost-saving and quality improvement could be true".[4]

Handwritten paper medical records can be associated with poor legibility, which can contribute to medical errors.[5] Pre-printed forms, the standardization of abbreviations, and standards for penmanship were encouraged to improve reliability of paper medical records. Electronic records help with the standardization of forms, terminology and abbreviations, and data input. Digitization of forms facilitates the collection of data for epidemiology and clinical studies[citation needed].

In contrast, EMRs can be continuously updated. The ability to exchange records between different EMR systems ("interoperability"[6]) would facilitate the co-ordination of healthcare delivery in non-affiliated healthcare 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.[7]

Electronic Medical Records in the United States

Usage

Even though EMR systems with computerized provider order entry (CPOE) have existed for more than 30 years, fewer than 10 percent of hospitals as of 2006 have a fully integrated system.[8]

In the United States, 38.4% of office-based physicians reported using fully or partially electronic medical record systems (EMR) in 2008[9]. However, the same study found that only 20.4% of all physicians reported using a system described as minimally functional and including the following features: orders for prescriptions, orders for tests, viewing laboratory or imaging results, and clinical notes.

Electronic medical records, like medical records, must be kept in unaltered form and authenticated by the creator[10]. Under data protection legislation, responsibility for patient records (irrespective of the form they are kept in) is always on the creator and custodian of the record, usually a health care practice or facility. The physical medical records are the property of the medical provider (or facility) that prepares them. This includes films and tracings from diagnostic imaging procedures such as X-ray, CT, PET, MRI, ultrasound, etc. The patient, however, according to HIPAA, owns the information contained within the record and has a right to view the originals, and to obtain copies under law.[11]

Electronic signature

Most national and international standards accept electronic signatures.[12] According to the American Bar Association, "A signature authenticates a writing by identifying the signer with the signed document. When the signer makes a mark in a distinctive manner, the writing becomes attributable to the signer."[13]

Technical Features

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[14]. Electronic Medical Records may include access to Personal Health Records (PHR) which makes individual notes from a EMR readily visible and accessible for consumers.

Event monitoring

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.[15]

GP2GP

GP2GP is an NHS Connecting for Health project in the United Kingdom. It enables GP to transfer a patient's electronic medical record to another practice, when the patient move onto the list of other practice[16]

Privacy concerns

A major concern is adequate confidentiality of the individual records being managed electronically.[who?] According to the LA Times, roughly 150 people (from doctors and nurses to technicians and billing clerks) have access to at least part of a patient's records during a hospitalization, and over 9000 payers, providers and other entities that handle providers' billing data have some access.[17]

In the United States, this class of information is referred to as Protected Health Information (PHI) and its management is addressed under the Health Insurance Portability and Accountability Act (HIPAA) as well as many local laws.[18]

In the European Union (EU), several Directives of the European Parliament and of the Council protect the processing and free movement of personal data, including for purposes of health care.[19]

Technical Standards

Though there are few standards for modern day EMR systems as a whole, there are many standards relating to specific aspects of EMRs. These include:

  • XML - a document format allowing easy interoperability.[20]
  • HL7 - messages format for interchange between different record systems and practice management systems.
  • ANSI X12 (EDI) - A set of transaction protocols used in the US for transmitting virtually any aspect of patient data.
  • CEN - CONTSYS (EN 13940), a system of concepts to support continuity of care.
  • CEN - EHRcom (EN 13606), a standard for the communication of information from EHR systems.
  • CEN - HISA (EN 12967), a services standard for inter-system communication in a clinical information environment.
  • DICOM - a standard for representing and communicating radiology images and reporting

Interoperability towards sharing records

In the United States, the development of standards for EMR interoperability is at the forefront of the national health care agenda.[2] EMRs, while an important factor in interoperability, are not a critical first step to sharing data between practicing physicians, pharmacies and hospitals. Many physicians currently have computerized practice management systems that can be used in conjunction with health information exchange (HIE), allowing for first steps in sharing patient information (lab results, public health reporting) which are necessary for timely, patient-centred and portable care.

Regulatory compliance

See also

References

  1. ^ http://www.providersedge.com/ehdocs/ehr_articles/Electronic_Patient_Records-EMRs_and_EHRs.pdf
  2. ^ Evans DC, Nichol WP, Perlin JB (2006). "Effect of the implementation of an enterprise-wide Electronic Health Record on productivity in the Veterans Health Administration". Health Econ Policy Law. 1 (Pt 2): 163–9. doi:10.1017/S1744133105001210. PMID 18634688. {{cite journal}}: Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  3. ^ "VistA:Winner of the 2006 Innovations in American Government Award" (PDF). The Ash Institute for Democratic Governance and Innovation at Harvard University's John F. Kennedy School of Government.
  4. ^ Jerome Groopman & Pamela Hartzband (12 March 2009). "Obama's $80 Billion Exaggeration". Wall Street Journal. Retrieved 3 March 2010.
  5. ^ Institute of Medicine (1999). "To Err Is Human: Building a Safer Health System (1999)". The National Academies Press. Retrieved 2006-06-20.
  6. ^ Adapted from the IEEE definition of interoperability, and legal definitions used by the FCC (47 CFR 51.3), in statutes regarding copyright protection (17 USC 1201), and e-government services (44 USC 3601)
  7. ^ "EHR Definition, Attributes and Essential Requirements" (PDF). Healthcare Information and Management Systems Society. 2003. Retrieved 2006-07-28. {{cite web}}: Unknown parameter |size= ignored (help)
  8. ^ Smaltz, Detlev and Eta Berner. The Executive's Guide to Electronic Health Records. (2007, Health Administration Press) p.03
  9. ^ National Center for Health Statistics: Preliminary Estimates of Electronic Medical Record Use by Office-based Physicians: United States, 2008 Retrieved December 15, 2009
  10. ^ National Archives and Records Administration (NARA): Long-Term Usability of Optical Media Retrieved July 30, 2006
  11. ^ Medical Board of California: Medical Records - Frequently Asked Questions Retrieved July 30, 2006
  12. ^ American Bar Association, Section of Science and Technology, Information Security Committee: Jurisdictions with legislation regarding electronic signatures Retrieved July 31, 2006
  13. ^ American Bar Association, Section of Science and Technology, Information Security Committee: Digital Signature Guidelines Retrieved July 31, 2006
  14. ^ Handwriting and mobile computing experts: [1] Retrieved August 20, 2008
  15. ^ M958 revision-Event monitors in PHS 1-02-02.PDF
  16. ^ GPsGP Website
  17. ^ Health & Medicine (2006-06-26). "At risk of exposure: In the push for electronic medical records, concern is growing about how well privacy can be safeguarded". Los Angeles Times. Retrieved 2006-08-08.
  18. ^ US Code of Federal Regulations, Title45, Volume 1 (Revised October 1, 2005): of Individually Identifiable Health Information (45CFR164.501) Retrieved July 30, 2006
  19. ^ European Parliament and Council (24 October 1995): EU Directive 95/46/EC - The Data Protection Directive Retrieved July 30, 2006
  20. ^ Nainil C. Chheda, MS (2005). "Electronic Medical Records and Continuity of Care Records - The Utility Theory" (PDF). Application of Information Technology and Economics. Retrieved 2006-07-25. {{cite journal}}: Unknown parameter |month= ignored (help)