Things got a lot more interesting for AI in the US.

Yesterday, President Biden signed an #AI #ExecutiveOrder (EO) to promote responsible and equitable development and use of AI across the U.S. Govt.

As part of the order, the #FDA was directed to develop a new regulatory framework for AI-powered #medicaldevice and software, and #HHS was directed to develop guidance to mitigate potential #bias in AI powered medical devices and software -- ensuring access to benefits of AI regrades of #race #ethnicity, or other demographic factors. The #NIH was also directed to invest in research on the responsible development of AI in healthcare.

So what does it mean for you?
📝 If you're working on AI Devices: between this and the #euaiact expect your regulatory landscape to keep shifting. Assess your level of design control rigor and ask yourself if you're meeting the spirit of this EO and the EU AI Act

📝 If you're working with population data: check your safeguards against potential bias. There's a lot of articles out there on the detrimental effects to public health in this arena (I've posted a fair amount 😉) to give you an idea if your #datacleansing practices are up to par.

📝 If you're responsible for staffing: expect the need for Software, AI, and Cybersecurity expertise to continue to rise. Invest in training for your existing staff. These topics weren't much of a thing when most of us were in college.

📝 While not traditionally considered part of AI, a fair amount of the EO focused on #cybersecurity. Expect the regulatory and standards landscape to continue to evolve here as well.

As always, Thomas Regulatory Consulting Group is here to support your Software and AI MedTech Compliance needs. You can register for our Webinar on the changing regulatory landscape featuring TUV SUD's Kenneth Fuh at www.regulatorygroup.net/webinars