Some big names in policy, federal government and providers convened this week in Washington, D.C. to discuss building a foundation for a big data economy to support personalized care and cancer treatment.

Hosted by Bloomberg Government and SAP, the conference started out of the gates with a barnburner of a conversation between Bloomberg News' Robert Langreth and Dr. Francis S. Collins, director of the National Institutes of Health (NIH), on the promise and the challenges that arise from the Precision Medicine Initiative (PMI).

“For most of the history of human medicine we have been trying to prevent illness and treat it when it happens based upon evidence gathered over time that applies to large groups [which] kind of treats humans as generic individuals,” Collins said. "But we're not average people. We all have individual differences that are important.”

President Obama has targeted $215 million for the PMI this year, $130 million of it to the NIH to build a patient cohort of at least 1 million people by 2019 to support precision medicine research.

Collins noted PMI is not just about genomics. It involves intersections of diet and exercise, socioeconomic status, inheritance, environmental exposures, and more over a long period of time to move the dial from a one-size-fits-all treatment approach to where healthcare recommendations become individualized, personalized, and precise.

He added NIH aims to open PMI enrollment up to the public around September or October and hopes to have 80,000 participants by the end of the year.

NIH has teamed with Vanderbilt University and Verily to start the first phase of the patient cohort. The NIH will also work with the Health Resources and Services Administration to develop partnerships with health centers that provide care to underserved communities to ensure diversity in the cohort.

Dr. Vindell Washington, principal deputy national coordinator at ONC, noted medical breakthroughs take about 15 or 17 years to make it into broad clinical practice. Thanks to technology, “I think we're finally at the cusp where...you can have breakthroughs and discoveries…that can become standard practice much quicker.”

As eyes are on health data interoperability this year, PMI is exciting not just for the obvious reasons but also because it could drive technology advancements and standardizations across the healthcare landscape. Collins said PMI is a great opportunity to weather the challenges that come with the attempt to synthesize EHR data along with data points from wearables, genomics, questionnaires individuals filled out, and more. “This is going to be the largest example of an opportunity to really make that work,” Collins said. “And if you can make it work for a million people, well you ought to make it work for about 330 million.”

The industry can't ruin patients' privacy expectations

Collins added that a large component of PMI’s success is to have the participants feel like they are in the middle of the project, not on the periphery. As he stated they intend to give a lot of information to participants, he noted confidence in the program is key. To that degree, enrollment may not be open until fall because NIH needs to ensure a secure database and interfaces that make sense to consumers. If the organization doesn’t take the proper security measures, “we will lose the confidence of the American public quickly,” Collins said.

Sen. Sheldon Whitehouse (D-RI) echoed this during a discussion about policy’s relationship to building the big data economy. "Policy is really, really important to help solve the problems of misguided competition in a market that's not a real-type market,” Whitehouse said. He noted policy drove an all-payer claims database initiative in Rhode Island, which forced payers to share data in an exchangeable manner.

However, Rep. Gene Green (D-TX), ranking member on the subcommittee of Health, House Energy & Commerce Committee, acknowledged there’s some fear among the public the federal government shouldn’t decide technology as the government doesn’t have a good experience of buying technology for itself.

Whitehouse stated there’s a “very hot stove” with individuals’ privacy concerns for health data leaking past them and the people they choose to have access to their information. “But beyond that, the opportunities for big data, particularly if its anonymized data, is immense. It's almost like a new internet opening up,” Whitehouse stated. “I think the prospects for new companies, new discoveries, new treatments and a way to address our extraordinarily wasteful healthcare system is really the promise…and has huge opportunity if we don't burn ourselves too badly on the hot stove of ruining individuals' privacy expectations.”

Entering into a new social contract

Deputy Chief Technology Officer for Data Policy and Chief Data Scientist in the Office of Science and Technology Policy DJ Patil noted his agency's their mission statement is to responsibly unleash the power of data to benefit all Americans. In healthcare, “we have been very low to touch it because it’s an uncomfortable conversation.”

However, he noted the rapidly changing landscape, especially in the sharing economy, is shaping new perceptions and expectations of what is personal in regards to an individual’s data. He noted that the results of that landscape, whether positive or negative, have yet to be seen in certain areas.

But healthcare data are sensitive. And individuals can be sensitive about sharing that data. Perhaps that means shifting the conversation from within the industry to outside the clinical walls. “If you ask 10 people about what big data is, you’d get 10 different answers,” Dr. Judith Salerno, president and CEO of Susan G. Komen, said at a panel. In an interview, Salerno told Healthcare Dive the patient’s voice is critical to big data efforts such as the cancer moonshot and PMI. She noted the industry has “done a very poor job in telling people why it’s important to share data. We’re never going to make progress unless we are able to do that.”

“Innovation is important; security is real and I think we have to recognize that and deal with it,” Dr. Dawn Milliner, CMIO at Mayo Clinic, said at a panel discussion, adding one of the largely-undiscussed challenges is the range of perceptions among patients as to what they're comfortable with in regards to data-sharing. There are many patients who are entirely comfortable with the idea and want their data to be shared but there are others who are not. “This needs to be a societal conversation and maybe a new social contract between providers and patients around what their responsibility is and what our responsibility is,” Milliner stated. “We're entering a new era.”