Category: Pharma/Life Sciences



FCC Moves Ahead with Connected Care Pilot Program Notice of Inquiry

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The Federal Communications Commission (FCC) announced its intention to launch a $100 million pilot program to provide greater access to health care for rural and low-income Americans, as well as veterans, through the use of telehealth last month. The FCC is now moving forward with a Notice of Inquiry (NOI), which will kick off a comment period on the proposed program.

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US FDA Approaches to Artificial Intelligence

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Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital, to market research at a benefits management organization, to optimizing manufacturing operations at a pharmaceutical company. The level of regulatory scrutiny of such systems depends on their intended use and associated risks.

In the U.S., for medical devices using AI, one of the key regulatory bodies is the Food and Drug Administration (FDA), especially its Center for Devices and Radiological Health (CDRH). CDRH has long followed a risk-based approach in its regulatory policies, and has officially recognized ISO Standard 14971 “Application of Risk Management to Medical Devices.” That standard is over 10 years old now, and therefore is currently undergoing revisions – some of which are meant to address challenges posed by AI and other digital tools that are flooding the medical-devices arena.

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