News & Analysis as of

Patient Safety Risk Management

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

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 In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

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

American Conference Institute (ACI)

[Virtual Event] 20th Annual Advanced Forum on Obstetric Malpractice Claims - November 18th, 8:45 am - 6:15 pm EST

Virtual Forum on Obstetric Malpractice Claims is taking place on November 18th EST. During this one-of-a-kind event, our unparalleled faculty of claims specialists, risk managers, medical experts – as well as an outstanding...more

American Conference Institute (ACI)

[Webinar] 19th Annual Advanced Forum on Obstetric Malpractice Claims - November 9th, 8:45 am - 6:00 pm EST

Obstetrics malpractice claims continue to be the most expensive within the medical malpractice arena. In 2019, there were several multi-million-dollar verdicts alone. During this one of a kind event, our unparalleled...more

Fisher Phillips

Whistleblower Lawsuit Can Teach Healthcare Employers How To Proactively Manage COVID-19 Risks

Fisher Phillips on

It is no surprise that COVID-19 whistleblower lawsuits are being filed against healthcare employers – and a recent claim filed by a former assistant director at a nursing home facility reveals ways in which healthcare...more

American Conference Institute (ACI)

[Event] Long Term Care and Senior Care Compliance, Risk Management, and Litigation Strategies - January 23rd-25th, Miami, FL

Join us as they share their insights on risk management, compliance, and litigation and help you develop the necessary strategies to avoid mistakes that cost facilities millions in jury verdicts annually. This year’s...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

Robinson+Cole Data Privacy + Security Insider

FDA Announces Playbook for Medical Device Cybersecurity

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

Hogan Lovells

Parsing products: FDA regulatory policy for multi-function medical devices

Hogan Lovells on

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

Hogan Lovells

FDA signals increasing focus on cybersecurity requirements

Hogan Lovells on

With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more

Hogan Lovells

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

Hogan Lovells on

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

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

Bricker Graydon LLP

Incident reports and peer review

Bricker Graydon LLP on

Incident reports involving patient care can be protected by Ohio’s peer review privilege. They can also be protected under the Patient Safety Quality Improvement Act (PSQIA), the federal statute creating patient safety...more

McDermott Will & Emery

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

McDermott Will & Emery on

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

14 Results
 / 
View per page
Page: of 1

"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