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Certification is primarily a way of enforcing that products meet certain criteria or standards. It can exert a powerful influence on products and markets—an influence that is particularly potent when the certification program is run or sanctioned by government. It is therefore critical that any certification program with government imprimatur be structured carefully to support clear public policy goals and avoid unnecessary restraints on market innovation. The American Recovery and Reinvestment Act of 2009 (ARRA) authorizes the National Coordinator for Health Information Technology to establish a voluntary certification program or programs for health IT. Although the proposed HHS program for testing and certifying EHR technology is technically voluntary, it will play a pivotal role in triggering eligibility for approximately $34 billion in stimulus funding and consequently will have a high degree of influence over technology development and choice in a rapidly changing health IT market. For these reasons, HHS must structure the certification program carefully to focus only on those elements that are necessary to achieving its policy goals while avoiding unintended consequences. Overall, the proposed program takes an appropriately measured approach to certification, as evidenced by its independence, limits in scope, emphasis on privacy and security, and flexibility for future innovations. Certification can be a tool for achieving some public policy goals, but it is good for some objectives and not for others. The role of HHS-sanctioned testing and certification is an important but limited one. The collaborative comments offer the following recommendations: HHS should create clear, standard language about the purpose and goals of its certification program, and its limitations in addressing important public policy questions raised by the adoption and use of health IT. HHS should establish ―labeling requirements for certified products that are consistent and clear to help providers and purchasers understand the scope of the testing and certification under the HHS program to implement ARRA financial incentives. In particular, the standard language should communicate the scope of certification, as well as its limitations both in terms of implementation experience and privacy and security. HHS should clarify the rules by which EHR modules may be exempt from testing against all privacy and security certification criteria. Except for the specific circumstances in which such services are being used to help health care providers and hospitals qualify for Meaningful Use incentives under ARRA, HHS should limit the scope of extending the current certification program to other forms of health IT such as electronic personal health records (PHRs) or health information exchanges (HIEs). In the eyes of the HHS-sanctioned testing and certification program, PHRs and HIEs should only be considered when packaged as EHR modules. In other words, when they are offered as components of a complete EHR or an EHR bundle, they may be tested and certified under the same rules as EHR modules, based on the limited scope of Meaningful Use. Otherwise, the public policy benefits are not clear for certifying PHRs or HIEs outside of the Meaningful Use context. HHS should clarify the type and scope of modifications that would require a product to be recertified.
In testimony before the National Committee on Vital and Health Statistics (NCVHS) Subcommittee on Standards, Carol Diamond, MD, MPH discusses the importance of setting clear health objectives for the federal investments in health IT. The testimony also emphasizes the importance of adopting a basic set of standards that can evolve over time, enabling information to move when and where it is needed to authorized individuals, the need for a comprehensive set of privacy policies, and accountability for results. The goal of health IT must be to achieve real health improvements, create jobs, and reduce unnecessary costs. It should not be primarily the creation of standards or the certification of software. Rather, standards and certification should support measurable health improvements. Health improvements are not achieved by the mere installation of software; they are achieved through the effective use of information for better decision-making.
The release of proposed federal health information technology (IT) “meaningful use” regulations and standards marks a major, positive step forward in the nation’s efforts to improve health care by putting modern IT tools at the fingertips of medical professionals and consumers alike. The public comment period is critical for ironing out workable details, and clearly we believe some important revisions will be necessary in the final regulation. But we must not lose sight of the urgent priorities of this effort: to improve health, increase cost-effectiveness, protect privacy, and encourage innovation and broad participation across many health care settings. The Markle Foundation, the Center for American Progress, the Engelberg Center for Health Care Reform at Brookings and three dozen diverse leaders in the health sector send a letter commending federal agencies for their work drafting proposed health IT "meaningful use" regulations and standards.
We acknowledge a need for federal governmental leadership that accelerates the potential of PHRs to empower the consumer. However, certification should not be a governmental focus at this time. The risks outweigh any potential benefits. If this recommendation goes forward, it will create momentum for certification is likely to ignore a broad range of critical policies and, as well, stifle innovation by prematurely locking in current approaches to PHRs and deter new entrant in a field that is newly developing. A premature process for certification--even if it begins as voluntary and attempts to limit itself to privacy, security, and interoperability--risks undermining opportunities to empower consumers and improve the quality of care.
In Phase 1 (2002–2003), the Markle Connecting for Health collaborative focused especially on moving the health care field toward the adoption of health care data standards, identifying "noteworthy" practices in privacy and security, and elaborating the role of the consumer and the personal health record.
Carol Diamond of the Markle Foundation, Marc Overhage of the Indiana HIE Organization, and Art Glasgow of Ingenix lead the panel discussion "Health Information Exchange and Health Care Stakeholders." This session is part of the Department of Health and Human Services' HIT Policy Committee and HIT Standards Committee's PCAST Work Group. The session is open to the public via live webcast. Webcast Information At least 10 minutes prior to the meeting start time, please go to: http://altarum.adobeconnect.com/PCAST If for any reason the link does not work, copy and paste the URL into your browser's address bar. Select "Enter as a guest." Enter your first and last names. Click “Enter Room.” Audio Conference Please note that space for the webcast is limited. If you are unable to log in, you may listen to the session via phone conference. US toll free: 1-877-705-2976 International Direct: 1-201-689-8798 Test Your System You will need to have an up-to-date version of Flash Player to view the web conference. Please test your system prior to the meeting by visiting Adobe Test Meeting Connection. When running this system test, you do not need to install the Adobe Connect Add-in (step 4 of the test), as that is not relevant to this meeting.
There has been an increasing recognition by both the public and private sectors of the ability to improve the quality and safety of healthcare with interoperable healthcare information technology (IT) systems. The need for standards adoption to enable information systems to exchange clinical data in a private and secure manner both within and across institutions is also more widely recognized than ever before. This paper will: (1) provide an overview of the significant activity that is occurring both within the public and private sectors regarding interoperable information systems and data standards; (2) provide a high-level summary of the evidence supporting the use of information technology in healthcare; (3) summarize both the limited research and anecdotal evidence that currently exists related to the value of connectivity across systems; (4) describe the importance of pilot projects for both better understanding the value and of an interconnected electronic health system and for developing an effective migration strategy towards such a system; and (5) highlight the additional work needed in this area.
Topics include setting objectives, information sharing and standards, a new urgency for results, new privacy policies, accountability for results, shaping technology policy to measurable health goals, and validating the use of standards with an open, market-based approach. There is also an appendix detailing lessons learned within the realm of information technology.
Considers whether efforts on technology standards absent alignment of policy objectives and financial incentives is "magical thinking" and reports that the nation's health IT coordinator and colleagues say the current policy strikes the right balance.
