Literature Review and Environmental Scan: Evaluation of Personal Health Records Pilots for Fee-for-Service Medicare Enrollees. The Standards Development Community


Standards development activities involve a number of stakeholders that represent the interests of the consumer, government, regulators, vendors, consultants, providers, informaticists, and other public and private stakeholders. The standards development community is tasked with addressing complex technical and implementation challenges, and also balancing a host of other policy, medical, and ethical considerations. This section provides a high-level introduction to the key players in the standards development community, and other leading organizations in the PHR space.

Exhibit 5 Key Players in PHR Standards Development

Exhibit 5 Key Players in PHR Standards Development

Exhibit 5 provides an overview of the major entities involved in standards development for PHRs.  A brief description of key players and their respective roles are provided below.


  • Federal and State Agencies. The federal government has played a key role in standards development for EHRs and has more recently focused attention on PHRs. The U.S. Department of Health and Human Services (DHHS) established the National Health Information Coordinator position in the Office of the National Coordinator (ONC) to facilitate the development of standards-based electronic health records. Within the ONC, the Office of Interoperability and Standards (OIS) coordinates with other DHHS offices to foster the use of standards and certified technology, and advance the development, adoption, and use of health IT standards nationally.[137] The Center for Medicare and Medicaid Services (CMS) is also currently engaged in testing the feasibility of utilizing personal health records for Medicare beneficiaries. The National Committee on Vital and Health Statistics (NCVHS) created recommendations for PHR standards.[138] Finally, the American Health Information Community (AHIC), a federally chartered advisory board, creates recommendations regarding the development and adoption of health IT and delivers these recommendations to the Secretary of DHHS.
  • Certification Organizations. The Certification Health Care Commission of Health Information Technology (CCHIT) decides whether vendor systems meet standards accepted by the Secretary of DHHS. Governed by a Board of Commissioners, CCHIT approves the final certification criteria and oversees a number of work groups that make recommendations on key issues related to standards. The CCHIT Privacy and Compliance workgroup has been tasked with PHR certification. Mark Leavitt, MD, MPH, Chair of CCHIT, announced CCHIT’s plans to certify PHRs by 2009 or 2010.[139]
  • Standards Development Organizations (SDOs). The American National Standards Institute (ANSI) facilitates the development of standards through an accreditation process. ANSI-accredited Standards Development Organizations (SDOs) produce clinical data standards (sometimes called specifications or protocols) for a specific health care domain. Health care domains include clinical and administrative data, pharmacy, medical devices, imaging, insurance, etc. Currently, more than 200 ANSI-accredited SDOs exist in different sectors, including Health Level Seven (HL7), National Electronics Manufacturers Association, Clinical Data Interchange Standards Consortium, The National Council of Prescription Drug Programs, World Health Organization, Regenstrief Institute for Health Care, College of American Pathologists, ASTM International, Centers for Disease Control, and many others. HL7 developed the PHR-S draft trial standard for usage, and ASTM created the Continuity Care Record (both will be discussed in greater detail later). ANSI decides whether the SDO’s standard meets the requirements necessary for accreditation. The ANSI’s Health Information Technology Standards Panel (HITSP) is a cooperative partnership between public and private sector stakeholders to achieve a broadly accepted set of standards that contribute to interoperability and health information exchange, and also to identify gaps in standards development. The HITSP focuses on breakthrough projects specifically recommended by the American Health Information Community, a federal advisory board, as priorities; projects focus on biosurveillance, consumer empowerment, chronic care, and electronic health records. The International Organization for Standardization (ISO) is a non-governmental organization that also develops information technology standards; the ISO is composed of standards development organizations from 157 countries.
  • Technical Committees and Workgroups. A variety of technical committees and workgroups exist in the PHR space. SDOs create workgroups within their overarching framework to address issues relevant to PHRs and EHRs, and to develop standards. The American Health Information Community (AHIC)’s Consumer Empowerment (CE) workgroup is working towards widespread adoption of PHRs over time.
  • Health Care Providers. Providers have a stake in standards development for PHRs, as there are many advantages to interoperability between PHRs and EHRs as well as PHRs and other systems. Standards ensure adequate linkages with the providers’ existing EHRs, fostering a more seamless exchange of patient information.[140] Standards also provide some assurance that the products that providers seek to purchase are capable of exchanging information with other systems.[141]
  • PHR and EHR Vendors. PHR and EHR vendors are involved in the standards development process. Some collaborate to develop new standards, and others review and test trial standards. A variety of vendors exist in the EHR and PHR space – each developing products that vary in terms of architecture, format, features, functions, and business model. Vendors also serve on workgroups and panels for HITSP and SDOs like HL7. Vendors have become increasingly interested in acquiring CCHIT certification; the certification demonstrates their commitment to the overarching goals of enabling interoperable health information exchange.
  • Health Plans and Health Care Organizations. Many health plans and employers have been advocates of the movement toward PHRs. Given that one of the main goals for health plans and employers is to reduce costs, this stakeholder group generally supports PHRs. PHRs are designed to involve patients in their healthcare, and may potentially reduce health care costs indirectly through increased prevention and disease management activities.[142]
  • Consumers and Consumer Advocates. Consumers are a critical part of the standards development process. In order for PHRs to be successfully adopted, consumers need to feel comfortable with the various standards and policies. Consumer advocate groups have been highly visible in standards development efforts as well, especially with regard to privacy and security issues. For example, the World Privacy Forum, a nonprofit, non-partisan public interest research group, explores PHRs and consumer privacy. In February 2008, the World Privacy Forum issued a consumer advisory about the privacy of PHRs and gaps in privacy standards for PHRs.[143]
  • Employers. Employers are beginning to offer PHRs to their employees. Recent research shows that there is an array of employer-based PHRs in existence, and each offers a variety of services.[144] A 2007 study of PHR uptake by large national employers concluded that employers will need to be involved in the PHR standards development process: ‘Employers need to facilitate and adopt standards for PHRs to enable their development, use, and interoperability. At a minimum, these standards should address the privacy, confidentiality, and security of PHRs.’[145] Given that some types of employers are not considered ‘covered entities’ under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), employers may be especially concerned about the development of standards for privacy.
  • Other Stakeholders. Research organizations, survey groups, information technology firms, experts in the field, and other stakeholders have been highly involved in standards development efforts – providing relevant research findings and fostering dialogue that has helped the industry to assess the needs in the PHR standards space. For example, the Markle Foundation explores how the use of technologies such as EHRs and PHRs can address public needs in the areas of health and national security.[146] Markle’s Connecting for Health provides policy and technical resources focused on networked health information sharing.[147] The American Health Information Management Association (AHIMA) is a professional community that works to improve healthcare via the advancement of best practices and standards for health information management.[148] RWJF and the California HealthCare Foundation are also supporting new research on PHRs through Project HealthDesign, a $4.4 million program that will work to stimulate innovation in the development of PHRs.[149]

Methods for Standards Development

The American National Standards Institute (ANSI) facilitates the development of standards from more than 200 ANSI-accredited standards developing organizations in the United States. The ANSI Board of Standards Review approves standards as American National Standards if they meet ANSI’s requirements. The ANSI process for standards development incorporates: stakeholder input and consensus; expert and public review and feedback; formal voting; and an appeal process.[150]

Standards are vetted through a group or ‘consensus body’ that includes a variety of relevant stakeholders, and then offered up to the public for a review and comment period as draft trial standards. After the comment period, feedback from the public as well as from voting members is incorporated into the draft standard. The appeal process is open to any person who believes that due process principles were not followed during the ANSI-accreditation process.

The International Organization for Standardization (ISO) uses a process that is similar to ANSI’s method for standard development. The features of ISO’s process include: creating a work group composed of experts from various countries to explore the standard; negotiating the details underlying the standard and gaining feedback from manufacturers, vendors, consumer groups, laboratories, governments, and other professionals; and an approval process that results in International Standard acceptance.[151] To be accepted as an International Standard, two-thirds of the ISO members that were part of the work group must approve the standard, and 75% of all ISO members that vote must approve the standard.[152]

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