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Biden’s October 30, 2023, Executive Order on AI: Key Takeaways for Health Care Stakeholders

The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI...more

Proposed Regulatory Oversight on the Emerging Use of Artificial Intelligence in Digital Health

Recent months have seen a heightened interest in artificial intelligence (“AI”)-based technology solutions. Although AI is derived from neural networks that date back to the 1940s, new technologies such as generative AI...more

Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired...more

Health Care Industry Must be Mindful of ‘Information Blocking’

Under the 21st Century Cures Act (Cures Act), the Health and Human Services (HHS) Secretary is mandated to have promulgated regulations by Dec. 13, 2017 that, among other requirements, prohibit “information blocking” as a...more

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

OCR New Guidance Aims to Help Medical Mobile App Developers Predict when HIPAA Obligations Might Apply

Predicting whether the activities of a mobile health application developer trigger legal obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) presents some new challenges – not surprising...more

FDA Releases Final Cybersecurity Guidance for Medical Devices

Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

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