Last month, the Office of Management and Budget (“OMB”) began its review of the much-discussed new Health IT Certification regulations, which include enhanced oversight of Electronic Health Records (“EHRs”) technology by the Office of the National Coordinator for Health Information Technology (“ONC”).

ONC administers a Health IT certification program for EHR technology.  On March 2, 2016, HHS published proposed regulations that would modify the IT certification in several ways. First, ONC would enforce the program’s requirements through direct review of health technology.  Among other things, ONC could order plans of correction and suspend and terminate certifications.  Second, the proposed regulations would give ONC the power to authorize and oversee the accrediting of laboratories that test health IT under the program.  Third and finally, health IT surveillance reports would become publicly available.   These proposed regulations were met with significant concern from the health IT industry (see, e.g., here and here).

The extent to which, if at all, the final regulations will address industry concerns will not be known until they are approved by OMB and published in the Federal Register.  While OMB review does not guarantee that the rules will be finalized, it is the last major step in the administrative process, and the fact that the regulations were sent to OMB in August increases the likelihood that they will be finalized before the end of the Obama administration in January 2017.

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Covington Digital Health Team

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with…

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with lawyers who understand how the regulatory, IP, and commercial pieces of the digital health puzzle fit together is essential. Covington offers unsurpassed breadth and depth of expertise and experience concerning the legal, regulatory, and policy issues that affect digital health products and services. To learn more, click here.