Medical Device Legal News with Sam Bernstein: Episode 11
On July 26, the U.S. Department of Commerce announced new guidance and tools to enhance the safety, security, and trustworthiness of AI systems pursuant to President Biden’s Executive Order on AI (covered by InfoBytes here)....more
Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more
Regulators and plaintiffs’ attorneys are increasingly focused on privacy harms related to the collection and use of personal data. Could privacy enhancing technology (PETs) be a solution to these concerns?...more
Article 5(3) of the EU ePrivacy Directive (ePD) requires consent for tracking cookies (unless exceptions apply). Although this rule is best known as the reason behind ‘cookie’ banners, it is technology neutral and applies to...more
Antitrust enforcers remained active across the globe, with the announcement by the FTC and DOJ of proposed guidelines that have an emphasis on tech mergers in the United States, and several investigations of major tech deals...more
The National Institute of Standards and Technology has issue a set of draft principles for “explainable” artificial intelligence and is accepting comments until October 15, 2020. The authors of the draft principles outline...more
• European Commission publishes survey on concept of “Specially Designed for Military Use,” and issues request for input for possible EU commercial policy measures targeting the United States • Netherlands introduces...more
• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...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On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology.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