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Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

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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

Morrison & Foerster LLP

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Gardner Law

New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers

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The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more

Ballard Spahr LLP

Heightened Cybersecurity Requirements for Medical Devices Passed Into Law

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Many privacy professional may have missed it, but In the run-up to the New Year — while many U.S. companies were focused on complying with the California Privacy Rights Act (CPRA) — Congress passed an appropriations bill that...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Volume 3, Issue 12

Universities Share Lessons Learned from Ransomware Attacks "According to a recent Sophos poll of IT professionals, 44 percent of educational institutions suffered ransomware attacks in 2020, and 58 percent of those hit...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

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 3, Issue 1

EHR Vendor Breach Lawsuit Seeks Security Improvements - "Patient portal hacking incident last summer affected nearly 320,000." Why this is important: On October 22, 2021, QRS Inc., a medical practice management system...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 17

China Passes Major Data Protection Law as Regulatory Scrutiny on Tech Sector Intensifies - A final version of the law has not been published but a previous draft included rules around requiring consent for data protection...more

Hogan Lovells

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

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On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Jackson Lewis P.C.

FDA Focuses Attention On Medical Device Cybersecurity Risks

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All companies in this day and age must devote some attention to cybersecurity risks. Regardless of industry, almost every entity maintains some form of personally identifiable information that requires protection (e.g.,...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

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• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

Holland & Knight LLP

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

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The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more

BakerHostetler

Capitol Hill Healthcare Update

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CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS - Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential...more

Hogan Lovells

Best practices for managing cybersecurity risks related to IoT-connected medical devices

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Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

K&L Gates LLP

K&L Gates Triage: FDA & Health Care Update: The Use of Real-World Data and Real-World Evidence in Medical Product Development

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In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and...more

Kelley Drye & Warren LLP

NY AG Enters Mobile Health App Enforcement Arena with Settlements Targeting Health Claims and Privacy Practices

New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they made deceptive advertisements and had irresponsible privacy practices. The...more

McGuireWoods LLP

Cybersecurity Threats May Impact Your Digital Health

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As the healthcare industry continues to embrace the Internet of Things, cybersecurity may present unprecedented health and privacy risks to patients. Wireless-enabled medical devices are increasingly common. For some...more

Arnall Golden Gregory LLP

Newest FDA Newsletter from AGG

Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more

Polsinelli

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

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New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

Arnall Golden Gregory LLP

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

Robinson+Cole Data Privacy + Security Insider

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

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