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October 2, 2016

Apple appears to be preparing a major move into the health care industry, expanding from its platform of fitness and clinical trial enrollment apps into an area that could include FDA-regulated sensors, advanced clinical decision support and even electronic health records.
The tech giant is cementing partnerships with big health systems and hiring scores of health care professionals. While the company is keeping mum about its plans, techie fans hope Apple will become the agent of transformation that makes patients, rather than providers or EHR vendors, the guardians of health data.
A 2014 report identified half a dozen prominent biomedical executives and experts at Apple. A search of the social network LinkedIn found that its staff has ballooned to at least 98 professionals engaged in health care or with significant medical backgrounds.
The current roster includes 22 staff with expertise in medical devices, for example, and 17 medical sensor experts. The staff include a designer who made a package of sensors and software to assess whether the sounds of one’s joints indicate osteoporosis, and an individual with expertise in atrial fibrillation.
Ten members of the group have EHR backgrounds, suggesting that the company may be designing better record software. Bloomberg reported last week that Apple was interested in building EHRs and decision-support software.
Some of the company’s current job listings included a business development executive with experience in corporate wellness; a data visualization expert to create software that “respects users’ privacy while giving them the ability to gain insights from health data;” and a “transformation business executive” to package Apple (and partners’) products as health care solutions.
A job ad — deleted last week — sought a legal counsel specializing in health care data privacy and FDA compliance. In December 2013, the company met with FDA, and notes from the meeting indicated it was trying to understand how to release useful products that would not be subject to regulation. The listing could indicate an interest in releasing regulated products.

Should the company seek to release FDA-regulated products, or use its products as a platform for other companies building agency-regulated products, partnerships with academic medical centers and big hospitals would be helpful. The company took the first steps in this direction last year with its ResearchKit release, which allowed investigators and companies to build clinical trial apps into the iPhone.
By all reports, the kit has been successful at speeding the enrollment of clinical trial subjects in the many academic institutions and biomedical companies that have used it in their research.
“I’m not sure they knew ResearchKit would take off like this,” said Ray Dorsey, a University of Rochester neurologist working on the mPower study, which has recruited thousands of Parkinson’s disease patients.
Some senior academics in health IT are curiously mum about Apple’s evident expansion, citing partnerships with the Cupertino, Calif.-based company.
Eric Topol of Scripps Translational Science Institute said his institute had a partnership with Apple related to the Precision Medicine Initiative, but wouldn’t go into further detail. John Halamka, CIO of Beth Israel Deaconess, said he was under a non-disclosure agreement when asked about a clinical trials partnership.
Figuring out Apple’s ultimate vision is difficult. CEO Tim Cook has suggested patients could use more information and technological guidance, saying that just as dashboard lights signal the need for an oil change, so too an app could signal various health problems to patients.
Such a device would require sensors that aren’t currently part of the Apple platform, but tea leaves suggest that more such devices are coming.
A coder at the company said on his LinkedIn page that he was building “a platform, a set of API’s, and a simple product that will bring what we believe will be a disruptive consumer healthcare application to the U.S. for the first time.”
A Texas doctor on LinkedIn said he was doing beta testing for an Apple app by “[p]roviding insight and perspectives regarding what is lacking in the IT world of medicine.
Apple has already made tentative steps into personal health record storage: users can download record summaries from their providers onto their iPhones. But the phone’s software doesn’t “parse” the records into distinct elements. It downloads each record in one gulp, and doesn’t sort out new and duplicated data.
Unhappiness with EHR technology has led consumer advocates and health IT advocates to push for personal health recordkeeping. The construction of a consumer product that aggregated patient health and fitness data, and offered nudges when appropriate, would fulfill many fond wishes from policymakers. A large part of the meaningful use program has focused on enabling patients to view, download, or transmit their data.
Patients haven’t shown much interest so far, however. An October 2015 data brief from ONC showed that 38 percent of patients had been offered access to their record, with 55 percent of that group taking advantage of the offer at least once. Experts argue about whether patients just don’t care, or the technology isn’t appealing enough to draw them in.
Policymakers have, to some degree, pushed on: the third stage of meaningful use requires EHR vendors to certify their use of open APIs, essentially contracts allowing users to get to their data, with the goal of facilitating patient access to records they can then transport to favored apps.
There have been some worries about whether these contracts would be standardized, which would enable developers to easily connect to EHR vendors. Last week, however, representatives from Epic, Cerner and Allscripts announced that their APIs would use the FHIR standard — meaning they would be open and standardized, a fact that former U.S. Chief Technology Officer Aneesh Chopra crowed about at an Friday event in Washington.
Those kinds of APIs would enable interoperability in a clinical setting and speed the Precision Medicine Initiative, Chopra said. As envisioned by President Barack Obama, volunteers to the initiative should be able to sign up from anywhere and contribute their data remotely — a chore that’s a lot easier with a smartphone serving as an aggregating middleman.
Read more: http://www.politico.com/story/2016/10/apple-expansion-health-care-229111#ixzz4MCXiiEp0
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