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…)
Trying to Tackle Big Data: European Union Launches Draft Data Act
On 23 February 2022, the European Commission (Commission) proposed a draft of a regulation on harmonised rules on fair access to and use of data – also known as the Data Act. The Data Act is intended to “ensure fairness in the digital environment, stimulate a competitive data market, open opportunities for data-driven innovation and make data more accessible for all”.
If adopted in its current form, the new rules will impose far-reaching obligations on tech companies (such as manufacturers of connected products and cloud service providers) and give national authorities new enforcement powers to sanction infringements with fines of up to EUR 20 million or 4% of annual global revenue, whichever is higher. (more…)
CPRA Law + Tech Series
WEBINAR
Sidley Senior Managing Associate Sheri Porath Rockwell (Chair, California Lawyers Association Privacy Law Section) and Stacey Gray, Director of Legislative Research & Analysis at the Future of Privacy Forum, will be leading a multi-session webinar series, CPRA Law + Tech, that focuses on the technologies and data practices at the heart of emerging state privacy legislation, including the California Privacy Rights Act (CPRA). (more…)
Building AI and Machine Learning Technologies: Data Licensing Tips and Traps
Data is the fuel for software development, and developers use historical data from existing products to train algorithms and build AI and machine learning models. Companies are well aware of privacy and regulatory restrictions on data use, but often do not consider the potential impact of data use restrictions on intellectual property ownership and use rights. (more…)
EU Council Publishes Changes to Artificial Intelligence Act Proposal
On 29 November 2021, the Slovenian Presidency (the “Presidency”) of the European Council published its compromise text (“Compromise Text”) on the European Union’s (“EU”) draft Artificial Intelligence Act (“AI Act” or “Act”) alongside a progress report on the Act. While the overall structure of the AI Act and many of its key provisions (including, those relating to potential fines for non-compliance), remain the same, there are some significant proposed changes to the Act which we have noted below including, for example, a new Article on general purpose AI systems. (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.