The U.S. Food and Drug Administration (FDA) released a new set of guidelines on August 15, 2023, concerning informed consent (Final Guidance).

Washington state recently passed the My Health My Data Act, which will almost certainly lead to an explosion of consumer lawsuits and follow-on insurance coverage disputes.

This Update is the third installment of the ongoing series covering Washington state’s new My Health My Data Act. The original impetus for the Act was the protection of reproductive rights, and it was signed into law alongside several other pieces of legislation focused on providing abortion and gender-affirming protections. However, because of the broad and vague definition of “consumer health data” covered by the legislation and because it applies to a wide range of entities, the Act may reach much further than might be justified by its original purpose.

As detailed in Part 1 of this ongoing series, Washington Governor Jay Inslee signed the state’s My Health My Data Act into law on April 27, 2023. In this installment, we provide an overview of the consumer rights bestowed by the Act and the obligations it imposes upon regulated entities and small businesses.

On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive.”