A recent mHealth panel discussion in Chicago underscored the rapid changes underway in the new wearable medical device industry. This industry is expanding at a rapid pace, from products like wireless blood glucose meters to consumer fitness devices like FitBit, Nike Fuel and Shine.
The panelists, including executives from Baxter, Blue Cross Blue Shield, Motorola and Catamaran raised concerns about the data collected from wearable devices. There were many questions around the use, ownership and liability of the personal data collected by these mobile devices.
Where does the consumer health data go? Where is it stored? Who is allowed to distribute the data? Are medical professionals who read and respond to the information eligible for reimbursement? Will there be a new ICD-10 code available for a doctor who responds to an alert from a patient’s wearable medical device? If a physician doesn’t respond to an alert, is she liable?
It’s fun to play with many of the new high tech consumer health toys touted at the Consumer Electronics Show, but for those of us in the industry, there are much bigger healthcare problems to solve. A recent article by Jason O’Grady in ZDNet wonders whether all the speculation over Apple’s highly-anticipated iWatch is actually masking the fact that it is going after the medical device market and not the crowded consumer activity tracker market. Rumors of meetings with the FDA would suggest that Apple is considering disrupting the enormous healthcare and remote patient monitoring industry.
It’s good to see a company like Apple wading into this market. Good user-centric innovation will help, but we need to make sure we are fully addressing all the “non-functional requirements” such as data governance, reimbursement, physician work-flow, and liability. In our excitement over technology, it’s too easy to run afoul of regulatory and cultural norms.
Yes, I know, healthcare just seems to get more and more complex! All the more reason to make sure we are engaging all the partners – tech, clinical, regulatory, patient, agency, pharma, payer – to find a legitimate solution that we can all live with.
That we can all live longer with…