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

Popular posts from this blog

Available Total Quality Management Tools

BayBiotech.NET Total Quality Management (or TQM) is a management concept coined by W. Edwards Deming. One of the principal aims of TQM is to limit errors to 1 per 1 million units produced. There are several TQM tools available today to analyze and assess qualitative and quantitative data. These tools can be examined and used to enhance the overall quality of the procedures, products or the work environment. Some of the most common TQM tools in use today are Pie Charts and Bar Graphs, Histograms, Run charts, Pareto Charts, Force Field Analysis, Ishikawa or Fishbone Diagrams, Tree Diagrams, Brainstorming, Flow Charts, Plan-Do-Check-Act cycle and Scatter Diagrams. Proper integration and use of these tools ultimately assist in processing data such as identifying collecting policies, enhancing work flows, ensuring client satisfaction by surveying their needs and analyzing them accordingly and creating an overall high level of quality in all areas of your organization. Use and choice...

A Facility Inspection Checklist

BayBiotech.NET Whether you are a Quality Assurance/ Compliance personnel planning to make a visit for a facility inspection, this checklist will help you prepare an inspection report based on the information that might be required to collect about the facility during the inspection. This checklist may help you evolve different forms for the inspection in order to accumulate complete information about the facility: 1.General information (a) name of establishment inspected (b) date of inspection (c) name(s) of the inspector(s) (d) date of last inspection. 2.Type of inspection Comprehensive, concise, follow-up, special, investigative, announced, and unannounced. 3.Licensing (a) licensing of premises (b) person with supervisory role in establishments (c) adherence to licensing provisions. 4. Activities undertaken on premises manufacturing, wholesale, importation, export, retail, hospital, pharmacy, clinic, nursing and maternity homes. 5. Adequacy and suitability of pre...

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...