President Biden Signs Sweeping Artificial Intelligence Executive Order
On October 30, 2023, President Joe Biden issued an executive order (EO or the Order) on Safe, Secure, and Trustworthy Artificial Intelligence (AI) to advance a coordinated, federal governmentwide approach toward the safe and responsible development of AI. It sets forth a wide range of federal regulatory principles and priorities, directs myriad federal agencies to promulgate standards and technical guidelines, and invokes statutory authority — the Defense Production Act — that has historically been the primary source of presidential authorities to commandeer or regulate private industry to support the national defense. The Order reflects the Biden administration’s desire to make AI more secure and to cement U.S. leadership in global AI policy ahead of other attempts to regulate AI — most notably in the European Union and United Kingdom and to respond to growing competition in AI development from China.
ICO Publishes Guidance on Handling Worker Health Data
On 31 August 2023, the UK Information Commissioner’s Office (ICO) published guidance on the handling of worker health data for employers (ICO Guidance). The ICO Guidance aims to provide tips and good practice advice about how to comply with applicable data protection legislation such as the UK GDPR when collecting and processing worker health data. Helpfully, the ICO Guidance also contains various checklists to help employers assess data protection considerations when processing worker health data.
EU, U.S., and UK Regulatory Developments on the Use of Artificial Intelligence in the Drug Lifecycle
Globally, the rapid advancement of artificial intelligence (AI) and machine learning (ML) raises fundamental questions about how the technology can be used. Drug approval authorities are now also taking part in this discussion, resulting in emerging and evolving guidelines and principles for drug companies.
Washington State Enacts My Health My Data Act, Broadly Regulating Health-Related Data With a Private Right of Action
On April 27, 2023, Washington Gov. Jay Inslee, a Democrat, signed into law the state’s My Health My Data Act (the Act), which will become effective on March 31, 2024 (June 30, 2024, for small businesses). Despite its name, this is a comprehensive privacy bill that will affect many entities, including those outside of the traditional “health” context. The rights and obligations may apply to individuals other than Washington residents, as the law defines consumers as including persons whose data is merely collected or otherwise processed in the state.
FemTech Has Been Warned: UK’s ICO Indicates Closer Scrutinization of FemTech Apps
On 4 April 2023, John Edwards, the UK’s Information Commissioner, stated that the UK’s Information Commissioner’s Office (ICO) would be “going after providers of women’s health apps and auditing them, and getting them to change any practices that are non-compliant.” Speaking at the IAPP Global Privacy Summit in Washington DC, the Information Commissioner indicated that this proposed strategy forms part of the ICO’s new “agile” initiative, which will focus on “areas of vulnerability, targeting…intervention [where] that has the greatest impact”.
New U.S. FDA Draft Guidance Outlines Path To Faster Modification of AI/ML-Enabled Devices
The U.S. Food and Drug Administration (FDA or Agency) has issued new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”1 that discusses a “science-based approach to ensuring that AI/ML-enabled devices can be safely, effectively, and rapidly modified, updated, and improved in response to new data.”2 This approach should offer more certainty to industry as FDA’s stated goal is to allow AI/ML-enabled devices to be modified faster in accordance with FDA requirements while being “built to adapt to the data and needs of individual health care facilities” and “adapt to deliver treatments according to individual users’ particular characteristics and needs.”3 Those wishing to comment on the draft guidance should note that the comment period closes on July 3, 2023.
New FTC Guidance for Mobile Health Apps
Healthcare providers, health plans, and technology companies that use mobile health apps to access, collect, share, use, or maintain information related to an individual’s health should take note of the recently issued Federal Trade Commission (FTC) Mobile Health App Interactive Tool. The purpose of the tool is to help mobile health developers determine the federal regulatory, privacy, and security laws and regulations that may apply to the use of a consumer’s health information, such as information related to diagnosis, treatment, fitness, wellness, or addiction. While the tool should not be considered legal advice and cannot guarantee compliance with legal requirements, it can help healthcare providers, health plans, and technology companies issue-spot to manage risk in this heavily regulated space.
It Is Now More Difficult For International Pharma To Transfer Data Out Of China
New measures for the security assessment of data transfers from China to other countries could make it harder for international pharma companies with China operations to transfer health data out of the country. Lianying Wang explains.
HHS Office for Civil Rights Releases Webinar on Recognized Security Practices: Provides Guidance on Mitigating Potential Violations of HIPAA
Pursuant to legislation passed in 2021, covered entities and business associates subject to HIPAA and facing potential regulatory enforcement may receive some credit lessening to reduce enforcement penalties if they had implemented Recognized Security Practices (RSPs) within the prior 12 months. However, what may constitute RSPs and how a covered entity or business associate can demonstrate implementation of RSPs to receive such credit had not been clear. Now, the Department of Health and Human Services is seeking to provide clarity. (more…)
One Step Forward, Two Steps Back: FDA’s Final Guidance on Clinical Decision Software Raises More Questions Than Answers
Recently, the U.S. Food and Drug Administration (FDA) published a suite of guidance documents relating to software, automation, and artificial intelligence. One guidance document in particular, addressing clinical decision support (CDS) software, may signal a tightening in FDA’s oversight on software tools with artificial intelligence and machine learning (AI/ML) that could introduce confusion and frustrate innovation in this important, fast-developing area. On October 18, 2022, FDA held a webinar to provide additional clarifications on this final guidance.
