HHS EHR Certification Details
Focus on Meaningful Use of EHR
- The National Coordinator shall determine the criteria for HHS Certification, which should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and (b) achieve the Meaningful Use Objectives.
- Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit.
- Industry advisory services can rate other aspects of EHRs that are important to purchasers, e.g., non-meaningful use features and functions and vendor viability and support capabilities.
Security, Privacy and Interoperability
- HHS Certification must specifically include requirements addressing all privacy and security policies described in ARRA.
- Aggressively establish new, very specific requirements for Interoperability and data exchange.
- Prioritize focusing on criteria for interoperability and data exchange for systems/applications that interchange data with a certified EHR.
Objective and Transparent Certification Process
- The process of defining HHS Certification criteria should be performed by ONC and separated from organizations that perform certification testing.
- Working with NIST, ONC should develop a comprehensive process for conformity assessment including testing, certification, accreditation and surveillance.
- ONC should develop an accreditation process and select an organization to accredit certifying organizations.
- Multiple organizations should be allowed to perform HHS Certification testing and provide certification. (vendors will need to get certification only from one certifying organization)
- Any updating of certification criteria should occur no more frequently than every other year and be done in time to allow EHR suppliers and adopters sufficient time for effective implementation.
Flexible Software Sources
- Certification support will be available to a wide range of EHR sources to support the "mandatory" nature of incentive payments based on Meaningful Use.
- Certification of components should be available so providers can achieve Meaningful Use with implementation of these components.
- All EHRs should be certified against the identical certification criteria, regardless of source.
- Provide an expedited process so that HHS Certified Products can be in the marketplace as soon as possible. Provide "Preliminary HHS Certification" so that vendors, who take a risk on the content of the final regulations, can be ready as quickly as possible when final regulatory approval is obtained.
- Certifications obtained during the transition period to be valid at least through 2011.
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