Certification, accreditation, conformity assessment; call it what you will, but some type of program to assure health information technology products meet certain benchmarks for safety is coming. And the federal government, while being a player and helping to facilitate, clearly is throwing the ball to stakeholders to get it done.
The new proposed regulatory framework for HIT safety favors a voluntary program that can be performed by the private sector or government. Private sector assessments may have advantages such as increased efficiency, promotion of consumer transparency and economic competition, and reduced government costs, according to the report from the Food and Drug Administration, Office of the National Coordinator for HIT and Federal Communications Commission. But government assessments may be more appropriate in assuring the safety and health of consumers. Which way to go should be decided with broad input from stakeholders, report authors say.
Importantly, the agencies do not propose that new or additional mandatory conformity assessments be required prior to the production, marketing or use of a specific health IT product or service. Instead, we recommend that these tools should be used and applied in a risk-based manner to distinguish high quality products and organizations from those that fail to meet basic performance standards or requirements. The agencies seek input on the value and role of voluntary conformity assessment tools for various health IT stakeholders during the different stages of the health IT product lifecycle, and whether various types of conformance testing can support innovation, such as by providing assurances during development phases to reduce risk.
However, the government reminds stakeholders that ONC already has and has used authority to create a more comprehensive certification program for the electronic health records meaningful use program, and adds a little warning: While ONC has focused on EHR technology certification, it also has authority to certify other types of health IT.
Report authors further talk about an accreditation program, which sounds a lot like a certification program. Accreditation is a procedure used to indicate that a third party or an individual is competent to carry out specific tasks, such as testing, inspection or certification. For example, a private sector, independent organization could serve as an accrediting body to independently assess an organization for adherence to recognized standards, guidelines, and/or best practices. Accreditation typically is voluntary although other entities such as purchasers or payers may require its use, authors add.
The agencies appear ready to accept one of these approaches for a voluntary, stakeholder-led program. Voluntary conformity assessment tools, such as certification, product testing and accreditation could be implemented by the private sector and applied in a risk-based manner to selected health IT.
The three agencies plan to hold a public meeting in May to solicit comments on the draft report and gather feedback on the outlined strategy and approach. A docket will be made available for the public to submit any additional comments.
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