Skip to main content

New ISO Guidelines for Protecting Electronic Health Records

BayBiotech.NET

Two ISO documents recently published provide harmonized principles and guidelines for the security of electronic health records.

ISO/TS 21547:2010, Health informatics – Security requirements for archiving of electronic health records – Principles covers the basic principles needed to securely preserve health records in any format for the long-term. In the document, a holistic process covering records maintenance, retention, disclosure and eventual destruction has been extensively covered.

Additional guidance for implementing ISO/TS 21547 is included in technical report ISO/TR 21548:2010, Health informatics – Security requirements for archiving of electronic health records – Guidelines. This report provides complementary guidelines to ISO/TS 21547, as well as a practical method and tools for the development and management of eArchives.

Main features include the retention and records maintenance for a patient for entire lifespan reaching to 100+ years regardless of time and place. The two ISO documents also take into account the dynamic nature of health data, which may be modified through time, its sensitivity and high security requirements, particularly as transferred between services organizations and healthcare providers, and more.

In addition, the two ISO documents also take into consideration new initiatives in the field, such as the growing trend to reinforce patients’ self determination and participation in their own healthcare, and the data that must be available to them.

The two documents were developed by ISO technical committee ISO/TC 215, Health informatics and to find out more on this follow the link: http://www.iso.org/iso/pressrelease.htm?refid=Ref1304

Comments

Post a Comment

Popular posts from this blog

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!
Post a Comment
Read more

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...
Post a Comment
Read more

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...
Post a Comment
Read more