Wednesday, March 13, 2013

Smartphones and tablets with health-related apps as “medical devices”- Patient Protection and Affordable Care Act -

Earlier this month Lawmakers from the House Energy and Commerce committee sent  a letter to FDA concerning whether the Patient Protection and Affordable Care Act could allow the FDA to define smartphones and tablets with health-related apps as “medical devices” — and levy new taxes on developers and smartphone makers under the health-care law.
Related training 
Mobile Medical Applications: Software Regulatory Requirements
FDA's Oversight of Mobile Medical Applications ("apps") for Use on Smartphones and Similar Mobile Devices

As per Washington post, Tuesday House lawmakers will conduct a three-day series of hearings next week to look at how the Food and Drug Administration should regulate medical applications on smartphones and tablets. Lawmakers from the House Energy and Commerce committee will look specifically at how regulation affects patients, physicians and developers looking to capi­tal­ize on the growing field of mobile health and medical apps.

- The biggest concern is due to the tax the R & D done by developers will get restricted by the new tax.
- Another concern is patients could use these apps to track valuable information, such as blood sugar levels or heart rates, which could help them work with their physicians to monitor their long-term health. But having apps collect all of that sensitive data also raises privacy concerns about how developers can use and repurpose that information.




The FDA has been mulling these issues for a couple of years, having been charged to devise a strategy that balances both innovation and privacy concerns.

However the market for health-related apps is already growing quickly. The market for mHealth app services will reach $26 billion by 2017, up from $718 million in 2011, according to a study from the consulting firm Research2Guidance.

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