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Cybersecurity › Protected Health Information › Food and Drug Administration (FDA)

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 -
Polsinelli

CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Polsinelli on

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more

Ankura

Is Your DNA Safe? DNA Sequencing Machines Found to Contain Critical Vulnerabilities

Ankura on

Key Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...more

Health Care Compliance Association (HCCA)

Privacy Briefs: June 2023

Health Care Compliance Association (HCCA) on

Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...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

Sheppard Mullin Richter & Hampton LLP

HHS Releases Cybersecurity Guide

Sheppard Mullin Richter & Hampton LLP on

The US Department of Health and Human Services recently updated its guide to help the private and public healthcare sectors develop cybersecurity protocols that address NIST’s Framework for Improving Critical Infrastructure...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report: Fall 2019

Wilson Sonsini Goodrich & Rosati on

Beware of “Most Favored Nations” Clauses in Commercial Contracts - Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

Holland & Knight LLP on

• 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

Wilson Sonsini Goodrich & Rosati

FDA Updates Cybersecurity Guidance for Medical Device Manufacturers

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) recently issued a dense, 24-page draft guidance, titled "Content of Premarket Submissions for Management of Cyber Security in Medical Devices" (the guidance). The guidance notes...more

Hogan Lovells

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

Baker Donelson

Significant Changes to Health Information Technology Found in 21st Century Cures Act

Baker Donelson on

On December 13, 2016, President Obama signed the 21st Century Cures Act ("Cures Act"), H.R. 34, into law. It enjoyed bipartisan support and was overwhelmingly approved by the House and Senate in recent weeks. The expansive...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

Cooley LLP

Blog: FDA Cybersecurity Workshop for Healthcare

Cooley LLP on

On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for...more

Sheppard Mullin Richter & Hampton LLP

Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

Sheppard Mullin Richter & Hampton LLP on

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more

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