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On February 24, 2024, the Federal Trade Commission announced that it will require software provider Avast to pay $16.5MM and prohibit the company from selling or licensing any web browsing data for advertising purposes to...more
As follow-on guidance to Office of Management and Budget’s (OMB) September 14, 2022 memo and the associated Executive Order on Improving the Nation’s Cybersecurity from May 2021, the Cybersecurity and Infrastructure Security...more
The National Institute of Standards and Technology (NIST) issued a request for public comment to help guide the development of the current and future state of technology in eight emerging technology areas. Those areas include...more
Consumer software providers will soon have the option to label their software as compliant with National Institute of Standards and Technology (NIST) standards for software security. On November 1, 2021, NIST published its...more
On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more
The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more
In a release aptly labeled “A Starting Point for IoT Device Manufacturers” the National Institute of Standards and Technology (NIST), an arm of the Department of Commerce, recently added to the discussion with the...more
In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...more
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more