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Healthcare Regulatory Standards

McDermott Will & Emery

Trending in Telehealth: July 16 – 22, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Gardner Law

FDA Highlights the Promise of AI in Healthcare

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On June 17, 2024, the U.S. Food and Drug Administration’s (FDA) Digital Health Center of Excellence (DHCE), published a blog article highlighting the promise of artificial intelligence (AI) in healthcare. In the article, the...more

Husch Blackwell LLP

Healthcare Founders Face New Exit Considerations

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Exiting a business, whether you are a serial entrepreneur looking to move on to the next project or a healthcare provider like a physician or therapist who has nurtured your practice for decades, can be difficult. After all,...more

Chambliss, Bahner & Stophel, P.C.

OCR Finalizes Post-Dobbs HIPAA Regulatory Changes Impacting Health Care Organizations

On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...more

McDermott Will & Emery

Trending in Telehealth: May 7 – May 13, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott+

Telehealth: Regulatory Questions Amid Legislative Uncertainty

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Where has the time gone? We have hit the one-year mark since the end of the COVID-19 public health emergency (PHE). Yes, you read that correctly. One year! One of the long-term consequences of the PHE was the shift in when...more

McCarter & English, LLP

New Jersey Regulatory Update Part II

Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more

McCarter & English, LLP

New Jersey Regulatory Update Part I

It is that time of year for our regulatory update. Parts I and II will discuss proposed and adopted rules from the second half of last year to the first quarter of this year that impact healthcare providers in New Jersey,...more

Health Care Compliance Association (HCCA)

An international standard for healthcare quality management

In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Manatt, Phelps & Phillips, LLP

DOJ Finalizes Regulations for Accessibility of State and Local Government Websites

Could Similar Regs for Commercial Websites Be Next? The Attorney General has signed off on regulations for the accessibility of state and local government websites and apps to people with disabilities, which will take...more

Akin Gump Strauss Hauer & Feld LLP

Geneva Insights - April 2024

The World Trade Organization (WTO) Committee of Participants on the Expansion of Trade in Information Technology Products (ITA Committee) meets on April 11. The committee holds regular meetings twice a year to review...more

Gardner Law

Highlights from OIG’s New Compliance Program Guidance

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The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more

Holland & Hart LLP

24-Hour Mental Holds In Idaho: New Standards, New Problems

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Since early 2022, the Idaho legislature has modified the standards for a patient’s capacity to consent to healthcare and 24-hour protective holds. This health law update summarizes the current rules for capacity and consent;...more

Rothwell, Figg, Ernst & Manbeck, P.C.

White House AI Order Balances Innovation And Regulation

On Oct. 30, President Joe Biden issued an executive order on safe, secure and trustworthy artificial intelligence. The executive order provides a sprawling list of directives aimed at establishing standards for AI safety...more

Foley Hoag LLP

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

Foley Hoag LLP on

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

Dechert LLP

Unprecedented Escalation of Injunction by French National Agency for Medicines and Health Products Safety

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In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more

Polsinelli

Third Party Administrator and Pharmacy Benefit Manager Licensing and Compliance Developments

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South Dakota - The South Dakota Division of Insurance (“Division”) recently took regulatory action against a TPA that has held a valid TPA registration in South Dakota since 2006.  In 2021, the TPA submitted its TPA...more

Proskauer - Health Care Law Brief

Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits

In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more

Nelson Mullins Riley & Scarborough LLP

The OIG Provides Stakeholders a Newly Expanded FAQ Process

The Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published a revamped frequently asked questions (“FAQs”) page and process on March 23, 2023, creating a new platform to...more

McDermott Will & Emery

HPE Miami 2023 | Buyer Beware: The Importance of Due Diligence in Healthcare Transactions

McDermott Will & Emery on

In this session, McDermott partners Matt Friendly and Ann Marie Brodarick moderated a panel discussion highlighting current considerations for buyers conducting legal and financial due diligence in healthcare M&A....more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Recommendations Regarding Electronic Systems, Records, and Signatures in Clinical Investigations

On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

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Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

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