From: Tech Republic
Apple, Fitbit, and Samsung are pre-qualified under a FDA fast track regulatory approval process for digital healthcare devices. Find out why this pilot program is ringing IoT security alarm bells.
The Internet of Things (IoT) is a significant part of the unstructured big data intake at healthcare organizations. It’s paramount to secure the input from healthcare IoT devices to maintain data privacy and prevent data breaches. A recent decision by the FDA will make it more complicated for big data custodians at healthcare institutions to keep pace with all of the IoT devices used in those settings and ensure that data the devices transmit is secure.
The FDA announced in July 2017 that it would fast track the regulatory approval process for digital healthcare devices by evaluating the companies behind the solutions instead of the actual solutions. Under the proposal, pre-certified companies will not need to provide the same level of pre-market data for each new digital health product, with some “low-risk” tools not needing any pre-market data at all. Among the companies that are initially pre-qualified under the proposed fast track program are Apple, Fitbit, and Samsung.
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