Time to advance a new oversight framework for health IT

By former Sen. Bill Frist (R-Tenn.), MD

(The Hill; December 11)

Innovations in digital technology have changed the way we live our everyday lives, and we are finally, just now, seeing them change the way that we deliver health care and manage our own health.

Now new technology makes it possible for us to track and improve our health and wellness by logging our personal habits like physical activity, food intake, and sleep, as well as helping us keep track of important health information like medications and blood pressure. Americans are also using social networks for much more than socializing. Through online communities patients and caregivers are sharing their stories and advice, getting emotional support, and even logging and sharing side effects of specific treatments and interventions. In addition, price transparency tools are emerging to help the consumer-patient make better informed decisions about the quality and costs associated with many medical choices.

Given the pace of technology in every other field, it is embarrassing to report that we are just now seeing a significant penetration of online communication between doctors and patients. However, it is imperative to the efficient delivery of modern medical care. In addition to moving medicine into the 21st century with online portals and secure emailing, we are also seeing the rise of telehealth. Telehealth or connected health has been aided by the slow but eventual uptake of electronic health records by the nation’s physicians and hospitals. We can now access patient data and support on best practices at the point of care between physician visits. As we combine this type of health information access with genomic information, we move one step closer to truly personalized medicine.

However, new innovation is always met with the age-old problem of existing regulation. Laws are understandably written with existing technology in mind and without flexibility for an evolving and unforeseeable landscape. What Congress envisioned 40 years ago is simply no longer relevant. To support invention and innovation we need a flexible, risk-based oversight framework that protects patient safety and reduces regulatory duplication.

To address this need the Bipartisan Policy Center has engaged hundreds of stakeholders and experts to develop a set of principles and recommendations for a new oversight framework for digital technologies in health care. The BPC framework—reflecting agreement among leaders across every sector of health care—calls for higher risk health information technology (IT) to be subject to oversight via public-private partnerships promoting adherence to a set of voluntary consensus standards and patient safety reporting. This framework would better support rapid response, learning, and improvement. Advancing and implementing this framework was discussed during an event I kicked off at the Bipartisan Policy Center last week.

The good news is this is on the radar for Congress, the administration, and the private sector alike, with everyone agreeing we need a risk-based framework for health IT.
Just last week during BPC’s event, Representative Marsha Blackburn (R-TN) confirmed that an updated version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013, which has 38 co-sponsors on both sides of the aisle, would be part of the 21st Century Cures package scheduled to emerge from the House Energy and Commerce Committee in January. Also last week, Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) introduced the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, which provides greater certainty regarding regulatory expectations, limiting the Food and Drug Administration’s role related to low risk medical software and mobile apps in alignment with the BPC framework.

And the administration is also onboard with the release in April 2014 of the FDASIA Health IT Report: Proposed Strategies and Recommendations for a Risk-Based Framework, which reflects many of the principles and recommendations outlined in the BPC report.

With growing agreement among and action by Congress, the administration, and the private sector we are on the cusp of evolving a regulatory environment that would reward innovation, protect patient safety, create jobs, and improve health and health care in this country. But we cannot stop now.

We demand online and digital access 24 hours a day to most of the other information in our lives and employ digital technologies and devices to make frictionless our daily business and leisure activities. Why should something as important as our health be any different? Sure there are barriers and privacy considerations, but we can overcome them. We know how right now. So, it is time to move on bringing health information technology up to speed with the rest of our lives. No more excuses.

Frist was senator from Tennessee from 1995 to 2007. He was Senate Majority Leader from 2003 to 2007, and is currently senior fellow at the Bipartisan Policy Center.

This article originally ran online: