Archive for February, 2009

Creating the regulatory framework we need

February 9, 2009

“In recent days, there have been misguided criticisms… [suggesting] that we can meet our enormous tests with half-steps and piecemeal measures… I reject these theories”

President Barack Obama, Washington Post, February 5th, 2009

The Obama Administration’s attempt to create the 21st century government “we want” has again confronted the 20th century government “we have”. The Washington Post reported on January 31st that in an attempt to add accountability to the recipients of Troubled Asset Relief Program resources the Obama team hit the brick wall of federal regulations. Turns out, the Paperwork Reduction Act of 1980 prohibits the Obama team from asking recipients what they did with the billions of dollars they received without Office of Management and Budget (OMB) clearance. As reported in The Post, this clearance process can take up to months and can only be waved when “lives are at risk”.

The Paperwork Reduction Act represents but one example of legislation whose good intention in one context blocks noble objectives in another. Biomedical researchers are all too familiar with the alphabet soup of regulations: FDAAA, 21 CFR Part 11, FISMA, HIPAA, to name a few. Moreover, these regulations are interpreted and enforced by a government that has been progressively hobbled for the past 20 years by bipartisan consensus (“government is the problem” – Ronald Reagan, “the era of big government is over” – Bill Clinton). The consequence is Lilliputian ropes binding the giant biomedical enterprise. These bindings impair natural synergies between research and care as well as foster a perverse set of misaligned incentives. For example, the Institute of Medicine’s Committee on Health Research and the Privacy of Health Information this week released a report in which it concludes: “the HIPAA Privacy Rule does not protect privacy as well as it should, and that, as currently implemented, it impedes important health research”.

The current economic crisis we face clearly indicates that the answer is not deregulation. When it comes to healthcare one can not count on altruism and organizational “better angels” to protect privacy, safety, security. Instead, what is needed is a holistic, systematic examination of the patchwork quilt of regulations in the context of 21st century biomedicine opportunities. A significant challenge confronting such an examination is that biomedicine is not currently constituted as a system but instead is a collection of highly fragmented, disconnected, silos.

The BIG Health Consortium™ represents a laboratory where such a systematic assessment could be performed. The BIG Health ecosystem contains the diverse stakeholders throughout biomedicine: consumers, care deliverers, researchers, government, academe, industry, non-governmental organizations. The consortium’s projects will represent real-world applications that demonstrate the regulatory challenges and in which solutions could be contemplated. Because of the diversity of the ecosystem it may be possible to anticipate “consequences” that would otherwise appear as “unanticipated”. The BIG Health Consortium™ inherits the caBIG® community’s pioneering work on data sharing, intellectual capital, and security. The framework created by this community represents solid foundational stones on which to build.

There are many additional natural partners to this endeavor. For example, I had the opportunity to present the BIG Health Consortium™ effort to a luncheon meeting of the American Health Lawyers Association Teaching Hospitals and Academic Medical Centers Practice Group. This group is on the frontlines of the day-to-day struggle of moving biomedicine forward. I invited them to join the BIG Health Consortium to help us create the necessary regulatory framework that balances private interest and public good and make 21st century biomedicine a reality.