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Articles

FDA Publishes Framework for Digital Health Technologies in Clinical Trials

By Alexandra B. Maulden Kyle Y. Faget

This blog focuses on U.S. Food and Drug Administration (FDA) published framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials. DHTs include a wide array of technologies, including software applications that run on a phone, wearables, and environmental sensors, among others. As DHT becomes more sophisticated, the technologies have the potential to play an even larger role in health care, including clinical research.

Articles

EU takes significant step forward in prohibiting greenwashing

By Thera Adam van Straaten, Louise Howarth, Kerry Boxall, Luisa Zukowski (Eversheds Sutherland)

This article discusses the EU Council and Parliament September 2023 announcement that they have provisionally agreed to new rules to specifically prohibit certain types of misleading green claims.

Articles

Whistleblowers - a new proposal in Poland

By Dentons

Poland's Ministry of Family and Social Policy published a new draft of the Whistleblowers Act on 12 April 2022. Learn about the key changes, including a new definition of whistleblower, anonymous submissions, internal notifications, data protection, criminal penalties, and more.

Articles

FDA’s New Guidance Proposes Flexible Use of AI in Medical Devices

By Jessa Boubker, Kyle Y. Faget, Nathan A. Beaver, Monica R. Chmielewski (Foley & Lardner LLP)

This article discusses the U.S. Food and Drug Administration's draft guidance on artificial intelligence/machine learning (AI/ML)-enabled devices.

The draft guidance — "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions" — was issued on April 3, 2023. 

Sample Forms, Policies, and Contracts

License Agreement - Trademarks

By Kilpatrick Townsend & Stockton LLP

This form is for use in licensing of trademarks that the licensor owns in connection with specified goods. Published in 2016, republished in 2023.

Checklists

Checklist of Necessary or Recommended Handbook Policies

By Ogletree, Deakins, Nash, Smoak & Stewart, P.C., Charles E. McDonald, III

The following is a checklist of common policies appearing in employee handbooks. Please note that the checklist is overly inclusive and that not every policy listed within should necessarily be contained in a particular employee handbook. (That being said, the checklist also does not include every possible policy that could potentially be included in an employee handbook.) Policies included in an employee handbook vary by the employer’s preferences, size, workforce, states (and municipalities) of employment, and type of industry or business.

Sample Forms, Policies, and Contracts

Sample Non-Discrimination Policy

This sample non-discrimination policy includes (a) Equal Employment Opportunity Policy and Affirmative Action Plan; (b) Americans with Disabilities Act Policy Statement; and (c) Anti-Harassment Policy.

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