Digital Health Transformation: A Practical Guide for Life Sciences Companies
In 2022, many if not most pharmaceutical, medical device, and other life sciences companies established strategies to innovate digital health technology complementary to their existing strategic focus. The digital transformation of the life sciences industry is still widely unfolding across the marketplace. In 2023 and beyond, the race is on to launch the next generation of digital health technologies to innovate the delivery of therapies to patients.
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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.
White House Publishes In-Depth Guidance on the Use of Automated Systems and Recognizes Privacy as Foundational Principle of Framework
On October 4, 2022, the White House Office of Science and Technology Policy published The Blueprint for an AI Bill of Rights: Making Automated Systems Work for the American People (the “AI Blueprint”). The AI Blueprint outlines non-binding guidelines for the development and deployment of automated systems and is the culmination of a year-long process of public engagement and deliberation.
Data Regulation Ramps Up in Europe: The AI, Data, and Data Governance Acts
Join Sidley and OneTrust DataGuidance for Part two of the “Data Regulation Ramps Up in Europe” webinar series, where our panel will discuss legislative proposals, including the Artificial Intelligence Act, the Data Act, and the Data Governance Act (DGA). (more…)
UK Consults on Algorithmic Processing
Algorithms touch upon multiple aspects of digital life, and their use potentially falls within several separate – though converging – regulatory systems. More than ever, a ‘joined up’ approach is required to assess them, and the UK’s main regulators are working together to try to formulate a coherent policy, setting an interesting example that could be a template for global approaches to digital regulation. (more…)
5 Global Data Protection Trends To Watch In 2022
*This article was first published by Law360 on January 3, 2022.
A recent discussion with Elizabeth Denham and Claudia Berg of the U.K. Information Commissioner’s Office provided ample food for thought on the direction in which data protection regulation both in the U.K. and internationally is headed, including key trends to watch for in data protection.
View article.
FTC Announces it May Pursue Rulemaking to Combat Discrimination in AI
On December 10, the Federal Trade Commission (FTC) announced it is considering a rulemaking on commercial Artificial Intelligence (AI). The purpose of the rulemaking, according to an advanced notice of proposed rulemaking (ANPRM) titled “Trade Regulation in Commercial Surveillance,” would be “to curb lax security practices, limit privacy abuses, and ensure that algorithmic decision-making does not result in unlawful discrimination.”
While not formally part of the rulemaking process mandated by the Administrative Procedure Act, advanced notices allow agencies to solicit public comment before drafting more specific proposals. The FTC has not yet issued privacy or artificial intelligence rules, though it has indicated that such rulemaking is on the horizon. The December 10 ANPRM is another signal that the FTC is gearing up to develop substantive privacy guidelines. (more…)
