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STAT+: New federal rules demand transparency into AI models used in health decisions

STAT

Federal health technology regulators on Wednesday finalized new rules to force software vendors to disclose how artificial intelligence tools are trained, developed, and tested — a move to protect patients against biased and harmful decisions about their care. Continue to STAT+ to read the full story…

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STAT+: As fear rises over AI, Google and Epic fight stronger regulation of the technology in health care

STAT

The opposition, which includes Google and Amazon as well as large health care providers, insurers, and medical software vendors, is focused on an attempt to put tighter guardrails around the use of AI by the Office of the National Coordinator for Health Information Technology.

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Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

FDA Law Blog: Biosimilars

FDA interprets the “software” definition to include software that is firmware or programmable logic in addition to software in a medical device (SiMD) or software as a medical device (SaMD). update servers, network connections, cloud, etc.) are cybersecure.

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Enhance Patient Experience through Electronic Health Records

assurecare

Electronic Health Records (EHRs) have become an integral part of the healthcare industry, providing a digital platform for storing, managing, and sharing patient health information.

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Antares Vision Group acquires software company, Smart Point Technologies

Express Pharma

Antares Vision Group has acquired, through its subsidiary rfxcel, 100 per cent of Smart Point Technologies, an Indian software product development company. The post Antares Vision Group acquires software company, Smart Point Technologies appeared first on Express Pharma. million, of which €5.4

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog: Biosimilars

If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.” The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents.

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FDA launches Digital Health Center of Excellence

pharmaphorum

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. The post FDA launches Digital Health Center of Excellence appeared first on.

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