Congress Pushes HHS for HIT Regulation

In my opinion, federal regulation of healthcare IT (HIT) would be a very significant barrier to innovation and progress in the field, but it may be in the cards if Congress has its way (see: Congress Pushes HHS to Regulate HIT). Here an excerpt from a recent article about this topic:

Legislation soon to be voted on in Congress and expected to pass lays the framework for federal regulation of health information technologies. The health I.T. language is part of a final version of the Prescription Drug User Fee Amendments Act of 2012, worked out in a House-Senate conference committee. Companies pay user fees, which in turn help pay for FDA regulatory programs. The bill requires the Department of Health and Human Services within 18 months of enactment to publish a report “that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regulatory duplication.” The regulatory strategy and recommendations would be published on the Web sites of the FDA, Federal Communications Commission, and Office of the National Coordinator for Health Information Technology. The HHS Secretary could convene a working group of stakeholders to give input on the strategy and recommendations. The conference committee agreement has been placed in S. 3187, which the full House and Senate will vote on before being sent to President Obama for his signature. The bill includes several steps to combat drug shortages....The legislation also sets deadlines for establishment of unique medical device identifiers.

Part of my distaste for federal regulation of HIT is based on my experience with FDA oversight over blood bank software. Luckily, this is the only component of LIS software that is regulated in this way (see: FDA and the Regulation of Lab Software and Algorithms). As soon as this regulatory oversight was required, further development of this type of software almost came to a complete halt. Moreover, LIS vendors that might have reasonably been expected to develop a blood bank module elected not to do so. The cost of software development for the blood bank became prohibitory. A rigid regulatory environment tends to favor the largest incumbent vendors of LIS software. They have regulatory and compliance staffs and are able to pick their way more easily through the regulatory maze and pass on the added cost to their clients. This suppresses innovation in the field because often the smaller vendors are often the most innovative.

More regulation in the EMR sector will also favor large, incumbent vendors. Because they have so many employees, they can exert tremendous influence over their state congressional delegations that can lobby on behalf of the company. The net result is positive spin for these companies. In this context, I am reminded of the strong pressure from Congress that has been exerted to deinstall the VA's much admired EMR, VistA, that consists of nearly 160 integrated software modules for clinical care, financial functions, and infrastructure. Despite several decades of successful operations and a long track record of success, members of Congress, working on behalf of the companies located in their home states, have lobbied to have it ripped out and replaced by a COTS (commercial off-the-shelf software) EMR (see: VistA replacement to look at future of IT). This is not to say that VistA is perfect -- only that open-source EMR software has much to recommend it and that the federal government can be swayed by Congressional pressure.

Comments

[Mark Pool-The Daily Sign-Out]

Bruce-Thanks for the insightful post (as usual). I agree with your analogy with FDA oversight of blood blank software and that it would likely have the same effect on HIT software.