Jodi G. Daniel
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FTC, ONC put vendors on notice
The Federal Trade Commission has some news for health IT vendors whose zeal for competitive marketshare outweighs their willingness to share data: they're watching, and will step in where necessary. "We are working with ONC staff to identify potential competition issues relating to health IT platforms and standards, market concentration, conduct by market participants, and the ability of health IT purchasers to make informed buying decisions," wrote FTC officials in a blog post this week.
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Interoperability by Design: FDA Issues New Final Guidance for Connected Medical Devices
The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information safely and effectively. For device manufacturers, this guidance provides clarity on how the FDA is thinking about interoperability and patient safety in the premarket submission process and provides considerations for manufacturers in the development and design of interoperability medical devices...
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