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Washington Debrief: Bill that Would Clarify what Medical Software the FDA Must Approve Advances

March 14, 2016
by Leslie Kriegstein, Vice President of Congressional Affairs, CHIME
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Congressional Affairs

Key Takeaway: A Senate Committee advanced legislation last week that explicitly clarified that the Food and Drug Administration (FDA) should not oversee electronic health records, administrative or billing software or software that enables intervention from a healthcare professional prior to diagnosing or treating a patient.

Why It Matters: There has been significant attention over the past few years to specify if the FDA should have oversight authority relative to clinical decision support (CDS) and other health software. The movement of the bill last week was just the latest iteration of Congressional interest in healthcare software oversight.

An amended version of the Medical Electronic Data Technology Enhancement for Consumers’ Health or MEDTECH Act (S. 1101), introduced by Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO), was passed by the Senate Health, Education, Labor and Pensions Committee last week by voice vote, with a few objections from Committee members.

Similar efforts have been undertaken in the House of Representatives led by Congresswoman Marsha Blackburn (R-TN), who sponsored the SOFTWARE Act which was included in the 21st Century Cures Act that passed the House last July.

Federal Affairs

FDA Takes on Interoperability

Key Takeaway: CHIME is spinning up a workgroup on the FDA Medical Device Interoperability draft guidance.

Why it Matters: Comments on the FDA draft interoperability guidance are due April 28th.  The intent of the draft guidance is to, “highlight the following items that medical device manufacturers should consider to provide a reasonable assurance of safety and effectiveness of their interoperable medical devices: 1) designing systems with interoperability as an objective; 2) conducting appropriate performance testing and risk management activities; and 3) specifying the functional, performance, and interface characteristics in a public manner such as labeling.” Anyone interested in joining the CHIME workgroup on this topic please contact Mari at  Workgroup dates for this call will be announced shortly. 

ONC Steps up Oversight of Certified EHRs

Key Takeaway: ONC published a proposed rule on increased oversight over certified EHRs.

Why it Matters: At present, review of certified health IT occurs through ONC-Authorized Certification Bodies (ONC-ACBs). ONC has proposed that, in addition to such review, that they would be able to directly review certified health IT and take actions when necessary that would promote health IT developer accountability for the performance, reliability, and safety of health IT. ONC’s first goal would be to work with health IT developers to remedy any nonconformities with certified health IT in a timely manner and across all customers, potentially eliminating the need for suspension and/or termination processes. These provisions are a complement to the current paths of review for certified health IT through ONC-ACBs and provide an additional tool to address public health and safety issues that may arise. Along with the rule ONC published a public comment template, fact sheet, and press statement which can all be found here.  Comments are due May 2, 2016.

Results are in on VBM

Key Takeaway: CMS made available results from the implementation of the 2016 Value Modifier for physicians and the adjustment factor that will be applied to physician groups that are subject to upward payment adjustments under the Value Modifier in 2016.