I recently attended Health Datapalooza IV. The attendance and energy were phenomenal. Organizations large and small and many developers, engineers, and coders came together to learn from each other and show off cool solutions, including new apps developed in real-time.
The focus was speed, innovation, and creative use of data generated and liberated by the increasing digitization of health care. Interestingly, many provider panelists reported that they have developed homegrown health IT solutions because vendor products do not always fit their unique and rapidly evolving needs.
Senior policy makers attended, including Farzad Mostashari, MD, National Coordinator for Health IT, Marilyn Tavenner, CMS Administrator, and Bryan Sivak, Chief Technology Officer for the Department of Health and Human Services. It was inspiring to see these visionary officials, representing “regulators,” so enthused by this outpouring of unregulated creative energy.
Contrast the Health Datapalooza ethos with the reality of some of the large, complex programs run by these agencies. For example, HIT incentive product certification has long lead times between when certification criteria are first discussed, rolled-out by vendors and used by providers. Detailed product requirements are debated and proposed by advisory committees that include relatively few developers or users of EHRs, and then run through a complex regulatory process culminating in detailed guidance for EHR developers that tells us what must be in our products to pass certification. In some cases, test scripts and requirements imposed by test methods and tools drive product development decisions, rather than value to end users.
Now I paint an admittedly gloomy and even overstated picture of certification. Although all parties involved, including ONC, CMS and vendors, recognize and are acting on opportunities for improvement, “it is what it is” in that the EHR incentive program, which has had very positive impacts, requires certification in its enacting law and almost any certification program will present many of these challenges.
Now, layer onto this environment recent interest in extending regulation to more health IT than is now regulated by the FDA or other federal agencies. For example, a federal advisory panel is developing recommendations for FDA, ONC, and FCC on their congressional mandate under the FDASIA law to develop a “risk-based regulatory framework” for health IT. This panel’s diverse members are having thoughtful discussions and are mindful of the need for innovation Still, there is the inevitable process of cataloguing the diverse types of health IT (Taxonomy Workgroup), identifying ways to control their development and use (Regulation Workgroup) and then trying to mitigate these first two steps (Innovation Workgroup).
Contrast the foregoing with today’s colliding worlds of technology and healthcare. We are experiencing the emergence and rapid morphing of new delivery and payment models needing health IT solutions that, in many cases, have not yet been defined, categorized or even developed. We see rapid growth of mobile solutions and technology-enabled consumers exemplified by the “quantified self” movement. Companies like GE are joining many smaller organizations in new models of software development such as agile and the “minimally viable products” of the Lean Start-up movement. These all feature rapid, iterative, flexible, and often modular development tied as closely as possible to customer needs and feedback.
As I outlined in an earlier post, one important implication of this narrative is to not try to move emerging health IT functions associated with new delivery and payment systems into the EHR incentive certification process. Another is to be skeptical about expansions of federal certification beyond what is needed to support meaningful use, and also to simplify existing certification programs. A third is to be very sensitive to the potential for unintended negative consequences of expanded regulation and oversight of health IT, as is being considered in the FDASIA process, although some additional oversight may be both positive and inevitable and a recent report of the Bipartisan Policy Center provides a useful framework for “low impact” oversight.
Frequently, calls for regulation and approaches like product certification are justified with the promise of increased predictability for consumers and producers. That view may be true in many instances. For health IT, however, with its accelerating velocity of change, the serious risk is that government engagement will in fact increase uncertainty and delay needed investments and innovation. Niall Ferguson’s new book, The Great Degeneration: How Institutions Decay and Economies Die, paints a vivid picture of how an accumulated web of regulations can stifle the innovation that is so central to our economic and national future. Let’s avoid that fate for healthcare IT.
“This post reflects my personal opinions, beliefs and thoughts and does not represent the official views of GE Healthcare”
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