(Story was updated at 2:43 p.m. ET)
A federal push might be needed to get drugmakers and electronic health record companies to buy into efforts to develop targeted treatments, President Barack Obama said Thursday at the first White House Precision Medicine Initiative Summit.
Obama said the project could ensure that patients get the care they need and would reduce wasteful spending in the healthcare sector. But he admitted some challenges needed to be addressed, perhaps in the form of new legislation.
A central component of the effort is a database that will have information voluntarily submitted by 1 million or more Americans. The genetic information is expected to enable clinical trials of targeted therapies. It will also use data from mobile health devices to correlate activity, physiologic measures and environmental exposures with health outcomes.
One challenge is getting electronic health record companies to create a mechanism that will allow patients to upload their data, Obama said.
“If I am sick and voluntarily want to join the other people who have a similar disease to mine, in donating our data to help accelerate cures, I've got to be able to work with electronic health record companies to make sure I can do that easily, and there may be some commercial resistance to that,” Obama said.
That might be a hard sell, says security expert Michael “Mac” McMillan, a Marine Corps veteran and CEO of CynergisTek, an Austin, Texas-based security consultancy. He said there's still a lot unknown about security and genetic information.
"My question is, what else can this data be used for” and would that create an incentive for some hacker to try and steal it, he said.
Cerner Corp., the electronic health record system developer, attended the summit and expressed support for the initiative.
“Cerner is committed to helping advance precision medicine through patient-enabled research to help break down data silos,” said Dr. David McCallie, Cerner's senior vice president of medical informatics. “It's an investment in the future of healthcare which will benefit the industry overall.”
The White House earlier Thursday released ideas on how to protect data submitted to the precision medicine initiative database. The White House will take public comments on the document through March 25.
But the project faces other challenges, like how to incentivize drugmakers to develop products that may only benefit a targeted group of people.
To address that, the White House has been working Sen. Lamar Alexander (R-Tenn.), chair of the Senate Health, Education, Labor and Pensions Committee on a legislative proposal that would provide a federal subsidy for those types of treatments.
Obama also said that some long-time regulations may need to be scrapped to make the precision medicine initiative work as a whole.
“We need to break down regulations that made sense in other eras of medicine, but don't work now,” Obama said.
The White House earlier Thursday released ideas on how to protect data submitted to the precision medicine initiative database. The White House will take public comments on the document through March 25.
In September, the White House announced it hoped to have the database up and running by 2019.
HHS' Office for Civil Rights will be issuing additional guidance on the rights of individuals who submit their information to the government under the initiative. The HHS and more than a dozen other agencies have already announced changes to the federal law protecting human subjects. Updates on the Common Rule, as it is known, included clearer consent for the reuse of stored blood or tissue in new research unrelated to their original use.
The Veterans Affairs Department is expanding the VA's Million Veteran Program, a participant-driven research cohort that similarly seeks to attract veterans to voluntarily provide their genetic information for clinical research. That project has more than 450,000 veteran enrollees, according to VA Secretary Robert McDonald.
He said he's looked at the way the VA is protecting the biological specimens and data of those veteran volunteers, adding, “I have no worry about security.”
McMillan said he found McDonald's remark “interesting,” if not troubling.
“I never ever say I'm not worried about security,” McMillan said. “As we've seen just recently, you never know what's going to happen.”
In 2015, data breaches in healthcare totaled over 112 million records.
The VA and the NIH aren't the only organizations that will have to store, protect and process massive data sets with the advent to genomics, said Russell Branzell, CEO of the College of Health Information Management Executives, a summit attendee.
“All of these huge health systems doing genomics, they're all going to have to deal with data aggregation at a size they've never dealt with before,” Branzell said.
CHIME participated in developing the security framework released Thursday and will probably comment on it as well, Branzell said.
He added in breakout sessions at the summit that there was pushing and pulling over the issues of security and privacy “as a protection mechanism” while increasing patient access to data. Those two things seem to be at odds.”
A health system is going to be concerned about making headlines after a breach rather than making the data easy and open, he said.
“At least they looked very proactively,” at security in the early stages of the concerted PMI effort, trying to address security issues that could arise, “on the font end,” Branzell said. “That wouldn't' have been the case a few years ago.”
Joe Conn contributed to this report.
