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Coverage of FDA's AI/ML Medical Devices Workshop - Part 2: FDA's Recent Digital Health Initiatives | Mintz - Health Care Viewpoints

In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s. ....

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HPE GreenLake Scores AI-As-A-Service Pact With AI X-ray Imaging Pioneer Carestream

HPE GreenLake Scores AI-As-A-Service Pact With AI X-ray Imaging Pioneer Carestream
‘HPE is a known leader in as a service, but their solutions were also more vendor agnostic from an applications stack perspective,’ says Carestream Health CTO Dharmendu Damany. ‘Also HPE had solutions that supported seamless deployment and management of the devices at the micro-edge, edge, private cloud and public cloud, so the scale was there.’
By
Steven Burke May 20, 2021, 08:00 AM EDT
Carestream Health, a pioneer of AI-based X-ray imaging systems, has inked one of the first Hewlett Packard Enterprise GreenLake AI-as-a-service pacts.
The three-year, multimillion dollar GreenLake on-premise cloud services deal is a “game changer” that opens the door to a new era of increased adoption of AI-based systems in healthcare, said Dharmendu Damany, chief technology officer at Rochester, New York-headquartered Carestream. ....

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FDA publishes Action Plan to regulate AI and ML based products

FDA publishes Action Plan to regulate AI and ML based products
The FDA has advanced an Action Plan focussed on possible means and methods of regulating AI/ML based products
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The Action Plan furthers and builds on concepts covered in a discussion paper released in April 2019
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On 12 January 2021, the US Food and Drug Administration (FDA) published a five part action plan which provides short-term actions to regulate products that incorporate artificial intelligence and/or machine learning (AI/ML). This Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan was released by the Digital Health Centre of Excellence (DCE). The DCE launched on 22 September 2020 and exists within the FDA s Centre for Devices and Radiological Health. The DCE s aim is to further the FDA s overarching dedication to the advancement of digital health technology. ....

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Five highlights from FDA's new AI device regulation Action Plan | Hogan Lovells

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On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence
released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
,” which describes the agency’s efforts to regulate products that incorporate AI. It is a direct response to stakeholder feedback to the April 2019 discussion paper
, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.” Although the Action Plan is light on details for AI regulation, it pledges specific actions that show FDA is moving forward with its “Predetermined Change Control Plan” regulatory framework for machine learning devices. The docket ....

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FDA's AI/ML-Based Software as a Medical Device Action Plan released

Today, the U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency's oversight of AI/ML-based medical software. ....

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