By Peggy Salvatore
Two items caught my attention last week that underlined the importance of thinking more expansively and inclusively about health IT as we thunder ahead with Meaningful Use 3 requirements and HHS’s health IT Roadmap.
Over the past few months, the onrush of incredible health technology appears to be overwhelming and outpacing the original national blueprints for the uptake and implementation of electronic health records as designed by Health and Human Services. HHS’s more flexible approach to next stages recognizes that reality. But as a system with entrenched interests, HHS’s challenge is to move that approach along a continuum toward embracing the rapid onset of tomorrow’s needs.
So, about those two items that underline the importance of widening our lens as we create our vision and plans for the future of the health IT infrastructure.
FDA’s Hamburg Points To Global Regulation
First, in her retirement speech to the National Press Club last week, FDA Commissioner Margaret Hamburg emphasized the importance of emerging global standards for drugs and devices under the newly organized International Coalitions of Medicines Regulatory Authorities (ICMRA), a sort of umbrella agency to harmonize standards among the FDA and its companion organizations around the world.
Hamburg said, “Globalization has multiplied the scale of our responsibility and heightened the need for us to work together to ensure safety, efficacy of the medical products that we oversee, and to promote the needed research in innovation in medical science.”
As a global agency that oversees tracking of approved drugs and devices, the ICMRA will look to individual countries and regions to participate using internationally interoperable standards.
IOM Report Looks to Globalize Clinical Trial Data Standards
Hamburg’s speech comes on the heels of a report released in January from the Institute of Medicine, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks, that discusses a pathway for sharing clinical trial data globally including overcoming privacy concerns, creating equitable funding mechanisms and protecting intellectual property.
If you’ve got a few hours, a great interest in this topic and an insatiable appetite for detail, you can download a free pdf of the report here.
The preface to the IOM report acknowledges that the landscape of electronic health records and the input of personal monitoring devices is changing the nature of data collection and so it makes its recommendations tentatively considering these uncertainties. The report states specifically that the future shape of clinical trial data cannot rely on familiar structures.
In a presentation last week, Deven McGraw a partner in Manatt, Phelps and Philip’s Healthcare Practice and one of the committee members who drafted the report, said in an online seminar sponsored by Manatt that the presumptions underlying the report included steps to protect patients’ data, that the data would be used for the benefit of patients, and that the data would be shared equitably among participants. The details about database funding, data sharing and privacy are beyond the scope of this brief blog, but for the discussion here the most important detail is the recommendation that the a global multi-stakeholder body be convened for the purpose of addressing the key infrastructure and technological challenges that sharing of clinical data will require.
Clearly, the promise of a fully realized health information infrastructure is that data can be shared for research (which treatments work best in whom, when and why) which can then applied at the point of care for the benefit of the individual (decision support), all done while protecting private patient information.
Pivot, Flex, Refocus
Margaret Hamburg’s parting words and the IOM’s report on sharing clinical trial data both point to taking a wide and long view as we forge forward in crafting national requirements for standards and interoperability by realizing we are leading into a global community.
If you consider these items in context of the HIMSS report that only 3.6% of hospitals in the U.S. meet its highest level (Stage 7) of interoperability and usability as of Q42014, the good news is that we have not run too far or too fast in one direction as the situation is still unfolding. Our tentative start allows for flexibility and pivots that may not have been immediately obvious when Meaningful Use was first conceived.
Pivot. Flex. Refocus. Remain open to a rapidly changing reality.