News & Analysis as of

Data Privacy Medical Devices Today's Popular Updates

Gardner Law

AI in Healthcare: Navigating Legal, Ethical, and Regulatory Frontiers

Gardner Law on

On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more

Hogan Lovells

Life Sciences & Health Care Horizons 2025

Hogan Lovells on

Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

Gardner Law on

The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Hogan Lovells

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

Hogan Lovells on

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more

Gardner Law

[Ongoing Program] SESSION 3: Privacy Policy Pop Quiz – Are You Ready? - August 8th, 1:00 pm - 1:45 pm CT

Gardner Law on

Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 2: Do I Really Need A Privacy Officer, DPO or CISO? - July 18th, 1:00 pm - 1:45 pm CT

Gardner Law on

Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Gardner Law

[Ongoing Program] SESSION 1: 10 Things You Should Know About Privacy, Consent, and HIPAA - June 13th, 1:00 pm - 1:45 pm CT

Gardner Law on

Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Alston & Bird

Why the New EU-U.S. Data Privacy Framework May Be Good News for Life Sciences Companies in the U.S.

Alston & Bird on

BACKGROUND - U.S.-based life sciences companies can be subject to the European Union (‘EU’) General Data Protection Regulation (‘GDPR’), even if they do not have any subsidiary, affiliate or other physical presence in the...more

Knobbe Martens

FDA Updates Cybersecurity Guidance

Knobbe Martens on

(May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 2023

In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy Act regulations. We also examine a...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 3, March 2023

Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more

Orrick, Herrington & Sutcliffe LLP

Global Authorities Ramp Up Medical Device Cybersecurity Expectations: What Medical Device Companies Need to Know

The last year has seen a multijurisdictional regulatory push for increased cybersecurity standards for medical devices. The new approaches, issued by regulatory authorities in the United States (U.S.), the United Kingdom (UK)...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 22, Number 9. Privacy Briefs: September 2022

Report on Patient Privacy 22, no. 9 (September, 2022) - More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey from the American Medical...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Volume 2, Issue 11

The PATCH Act: Protecting Medical Devices from Cyber Attacks - In a previous issue of Decoded, we discussed the alarming fact that many medical devices, including those implanted in patients' bodies, are leaving the...more

Spilman Thomas & Battle, PLLC

The PATCH Act: Protecting Medical Devices from Cyber Attacks

In a previous issue of Decoded, we discussed the alarming fact that many medical devices, including those implanted in patients' bodies, are leaving the manufacturers with known cybersecurity flaws. Due to these known flaws,...more

Sheppard Mullin Richter & Hampton LLP

Digital Health in the Metaverse: Three Legal Considerations

The metaverse has been described as the “next frontier” and the “new era” of healthcare. Although still a loosely defined and relatively broad term, the “metaverse” generally refers to a shared virtual environment accessed by...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 2022

In this month’s Privacy & Cybersecurity Update, we examine the FTC chair’s comments suggesting a potential shift in its approach to data privacy regulation, the European Data Protection Board’s request for comment on its...more

Hogan Lovells

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more

Nelson Mullins Riley & Scarborough LLP

[Virtual Event] 2022 Central Florida Health Law Forum - April 28th, 11:00 am - 7:00 pm EDT

Please join Nelson Mullins Riley & Scarborough for the 2022 Central Florida Health Law Forum. This year, the event will be offered in-person or virtually and will include networking opportunities and a series of educational...more

Health Care Compliance Association (HCCA)

Securing Problematic 'Legacy' Devices: Be Part of Procurement, Push for Info

Report on Patient Privacy 22, no. 3 (March, 2022) - Typically a “legacy” describes the lasting impact of an influential person or movement, most often in a positive sense. Not so with medical devices. When legacy is applied...more

Health Care Compliance Association (HCCA)

2022 Outlook: More Dangerous Ransomware Coupled With Inadequate Security Practices

Report on Patient Privacy 22, no. 1 (January, 2022) - As the COVID-19 pandemic enters its third year, real “security fatigue” with pandemic-related issues will combine with cybercriminals’ increasingly sophisticated...more

Reveal

There Are More Challenges in Managing Discovery in Healthcare Than You Probably Realize

Reveal on

A few months ago on this blog, I wrote about using Artificial Intelligence (AI) to keep up with the “alphabet soup” of compliance. An important area to address from a compliance standpoint is health data and at least two of...more

41 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide