News & Analysis as of June 1, 2025

Cybersecurity › Patient Privacy Rights › Medical Devices

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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 -

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

Polsinelli on 2/13/2025

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

Healthcare Industry Team 2024 Year in Review

BakerHostetler on 1/22/2025

As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

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

Health Care Compliance Association (HCCA) on 9/13/2022

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

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on 8/17/2022

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Life Sciences: Connected Medical Devices in the Cloud During COVID-19

BakerHostetler on 9/4/2020

The Pandemic has fast-tracked the use of telehealth services. Hussein Akhavannik discusses how medical device companies are looking to add to or expand remote monitoring capabilities. However, some capabilities raise legal...more

Digital Health Report: Fall 2019

Wilson Sonsini Goodrich & Rosati on 11/20/2019

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

FDA Issues Cybersecurity Alert to Health Care Providers and Device Manufacturers

Baker Donelson on 10/4/2019

The U.S. Food and Drug Administration took the unprecedented step this week of issuing an alert to health care providers and device manufacturers about potentially serious security flaws that may allow hackers to remotely...more

Privacy Tip #197 — Medtronic 508 (MiniMed) Insulin Pumps Recalled

Robinson+Cole Data Privacy + Security Insider on 7/3/2019

In my 25 years in the data privacy and cybersecurity profession, this is the first time that I believe a medical device has been recalled because of a cybersecurity risk. This week, Medtronic recalled its 508 Insulin pumps...more

K&L Gates Triage: Artificial Intelligence in Health Care

K&L Gates LLP on 7/13/2018

Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

Recall Highlights Medical Device Cybersecurity Issues

Knobbe Martens on 9/16/2017

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

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