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Cybersecurity › Medical Devices › Department of Health and Human Services (HHS)

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
Arnall Golden Gregory LLP

Healthcare Authority Newsletter - April 2025 #2

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News Briefs - Judge Blocks Trump from Cutting Billions in State Health Funding - A federal judge said she will grant a request from 23 states to issue an emergency block on the federal government's rescindment of billions in...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

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On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

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Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #1

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News Briefs - Number of Official Physician Union Drives Soared Over Two Years - While fewer than 10 percent of U.S. physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed...more

Holland & Knight LLP

Safeguarding Health Information: Takeaways from HHS and NIST 2024 HIPAA Security Conference

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President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

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Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

McDermott+

McDermottPlus Check-Up: January 5, 2024

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Congress Returns Next Week to Face Imminent Funding Deadlines. The Senate will return to session on January 8, and the House will return on January 9. Lawmakers face an immediate time crunch on FY 2024 appropriations, as the...more

King & Spalding

HHS Releases Cybersecurity Strategy for the Healthcare Sector

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On December 6, 2023, HHS released a concept paper that outlines the Department’s cybersecurity strategy for the healthcare sector titled, “Healthcare Sector Cybersecurity Strategy.” HHS reports that cyber incidents in...more

Alston & Bird

Health Care Week in Review: Government Shutdown in Sight, CBO Releases Report on CMMI’s Effect on Federal Spending

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

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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

Health Care Compliance Association (HCCA)

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

Health Care Compliance Association (HCCA) on

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 3, Issue 13

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AHA Expresses Member Support for PATCH Act, Medical Device Security "In a letter addressed to Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI), who first introduced the PATCH Act, the AHA said that the association and...more

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

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In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 3, Issue 1

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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

Health Care Compliance Association (HCCA)

2022 Outlook: More Dangerous Ransomware Coupled With Inadequate Security Practices

Health Care Compliance Association (HCCA) on

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

Akin Gump Strauss Hauer & Feld LLP

FDA Appoints Acting Director of Medical Device Security, Signaling Increased Commitment to Medical Device Cybersecurity

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The U.S. Food and Drug Administration (FDA) announced that the newly-created post of Acting Director of Medical Device Security has been filled by Kevin Fu, a University of Michigan associate professor and founder of the...more

Jackson Lewis P.C.

FDA Names First Acting Director Of Medical Device Cybersecurity

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The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created...more

King & Spalding

HHS Issues Final Rules Implementing Stark Law and Anti-Kickback Statute Reforms

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On Friday of last week, HHS published two long-awaited final rules implementing significant changes to the regulations under the Stark Law and Anti-Kickback Statute (AKS). The two final rules are: (i) Revisions to the Safe...more

Rivkin Radler LLP

OCR Updates Mobile Health App Resources

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The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently unveiled a new website with updated guidance and resources for mobile health app developers regarding the HIPAA Privacy, Security, and...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #4

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Food/Dietary Supplements - FDA Provides Update on Frozen Berry Sampling – The FDA stated, “As of September 30, 2019, the FDA has tested 339 domestic samples and 473 import samples of frozen berries. ...more

Jones Day

The FDA and Cybersecurity: How the Agency is Addressing Cybersecurity Risks to Medical Devices

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The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks. The Result: Over the last five years, the Food and Drug...more

BakerHostetler

Capitol Hill Healthcare Update

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Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: Pharma industry CEOs testify before a Senate committee; House and Senate panels probe...more

Roetzel & Andress

HHS Releases Guidance For Health Industry On Voluntary Cybersecurity Practices

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The Department of Health and Human Services (HHS) has released a publication entitled the "Health Industry Cybersecurity Practices (HICP): Managing Threats and Protecting Patients." The HICP was prepared in response to the...more

McDermott Will & Schulte

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

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In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

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