The Electronic Health Record Association, which represents 40 EHR developer companies whose products are in use at a majority of hospitals and physician practices today, applauds an FDA Regulation workgroup recommendation that healthcare technology, such as EHR systems, should not be treated as medical devices and should remain unregulated.
However, the group, in a Nov. 6 letter to HHS Secretary Kathleen Sebelius, asked for clarification on a number of topics, including clinical decision support, medical device accessories, reporting of safety event and post-market surveillance and “Class 0.”
“We are not convinced that most HIT not regulated as a medical device should receive a new ‘Class 0’ device classification by the FDA. Such a classification and application for a formal regulatory approach to HIT is not warranted in our view,” stated the letter signed by the EHR Association Executive Committee members, whose chair is Michele McGlynn, senior director, strategy and operations at Siemens.
The Association recommended the following:
- Any definition of HIT used in a new risk-based policy framework should align with existing market definitions. The focus should be on what specific types of HIT are subject to which types of regulation or oversight, if any.
- A patient safety risk framework and examples should be used as building blocks to develop a robust and transparent plan that that would allow application of oversight by level of risk and associated costs and benefits of oversight. Any such framework must include weights for risk elements and a model to combine results.
- To the extent that enforcement discretion is used, it should be used in a manner that creates greater predictability as opposed to regulatory uncertainty, with enforcement discretion identified as the clear outcome of a considered policy process and one that can be expected to remain in place for some time. We believe that the approach taken related to the recent FDA guidance on mobile devices is a good example of providing useful guidance and minimizing uncertainty, while allowing the framework and the market to evolve. As a general proposition, we urge that any deliberations regarding increased oversight of HIT be conducted in ways that increase predictability and certainty for developers and providers
