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Washington Highlights

21st Century Cures Initiative Hosts Digital Health Care Roundtable

June 27, 2014— The House Energy and Commerce Committee June 24 held a roundtable discussion on digital health care. Hosted under the auspices of the committee’s 21st Century Cures Initiative, the roundtable featured representatives from the Food and Drug Administration (FDA), academic institutions, providers, patient groups, and industry.

Participants focused on the potential for new digital technologies, more robust electronic health records, and the vast amounts of data being generated by genomic and other research to transform the health care system.

Energy and Commerce Chair Fred Upton (R-Mich.) opened the session saying, the “digital age offers exciting potential. But we want to understand what obstacles might stand in the way of advancement."

Jeff Shuren, M.D., J.D., director, Center for Devices and Radiological Health, FDA, emphasized the importance of interoperability, noting, “[W]e're not just talking about individual technologies, we’re talking about systems and systems within systems.” He also said the FDA wants “to engage in smart regulation. That means knowing when to regulate and how to regulate... [W]e’re trying to provide greater predictability and clarity. But we’re also moving out of the way when it makes sense to do so.”

Joseph M. Smith, M.D., Ph.D., chief medical and science officer, West Health, talked about a “learning healthcare system” that takes full advantage and knows “the best way to manage you...” However, he cautioned that we need to make sure these new technologies “work together in a symphony around patient care and not the current cacophony that exists in our healthcare systems.”

Describing the development of Gleevac, Brian Druker, M.D., director, Knight Cancer Center, Oregon Health and Science University, said, “It took us 25 years to identify the molecular abnormality that drove this leukemia and 15 years to develop the drug.”

He explained his lab is starting another clinical trial of a targeted drug for another leukemia, saying “this work came about because of a patient sample we took in our clinic. We did a whole genome sequencing on this patient sample. We identified the driving molecular abnormality.... [W]e also did drug screening in my laboratory and identified a drug that shut down this molecular abnormality. In less than six months after obtaining this patient sample, we’ve now treated three patients... So, in six months, we’ve compressed 40 years of work because of the technologies that we have available to us today.”

Citing the huge amounts of data generated by whole genome sequencing of tumors, he said, “[T]o transfer that data from one institution to another would take you 23 days over the current pipeline. So, clearly what we need is cloud computing where we bring the computer to the data rather than having to transfer the data.”

He praised the federal government for requiring coverage on clinical trials for Medicare patients, saying, “This is critical to the success of getting patients on clinical trials.” He observed the FDA is doing extremely well with their breakthrough pathway but he said he still thinks “there are areas for improvement for getting life-saving medications to patients more quickly. NIH funding can always improve. We’re at an incredible opportunity to see progress and we need more funding to make these breakthroughs happen.”

Dr. Druker said, “We have the ability to do remarkable genomic testing but we don’t necessarily have the reimbursement infrastructure in place for this to happen.” And he noted the serious privacy and security concerns that must be addressed to permit access to data for research.

Cleveland Clinic’s Chief Information Officer Martin Harris, M.D., talked about using technology to redesign the delivery of health care, moving it closer to the patient’s home. He said, “[W]e can use the power of that computing to enhance the decision making of our patients, make them far more knowledgeable, and actively engage them in their own healthcare and healthcare decision making.”

Dr. Harris also discussed efforts at the Cleveland Clinic to do reverse clinical trials, saying “we aggregate the data first, we simulate the trial, we put in the inclusion and exclusion criteria, and we can have a very clear understanding of whether or not that clinical trial can actually be conducted and whether we can get enough patients to draw a scientific conclusion.”

Paul Magelli, CEO, Pervasive Health, said, “What we know about the clinical trials process today is that’s hugely inefficient... it’s hard to match your patient with the trial.” He described the current limitations of clinicaltrials.gov and suggested investing in an upgraded system that would permit automated matching of patient records and available trials.

Toward the end of the discussion, Chairman Upton noted “we’re not seeing legislation this year, it's just too fast.... [W]e’re hoping by the end of the calendar year, we’ll be ready with something that will then move next year, that's the goal.”

Contact:

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org