News & Analysis as of

Patient Safety

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

by Hogan Lovells on

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more

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

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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

FDA signals increasing focus on cybersecurity requirements

by 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

Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications

by Ropes & Gray LLP on

The rules regarding truthful, non-misleading communications by medical product manufacturers have long been unclear. In recent years, there have been significant developments in the case law, as well as in FDA guidance and...more

FDA Limits Sales of Birth Control Device

by Harris Beach PLLC on

The Food and Drug Administration (FDA) has taken the unusual step of limiting and restricting sales of the birth control medical device, Essure®, to healthcare providers who provide adequate risk versus benefit discussions...more

Connected medical device vulnerabilities continue to impact manufacturers, health care

by Thompson Coburn LLP on

Recently, Thompson Coburn’s Life Sciences Decoded blog described several FDA initiatives to increase the safety and reliability of the emerging connected device market and discussed data privacy as it pertains to medical...more

Energy and Commerce Committee Leaders Investigate Allegations of Patient Safety Issues at Hospitals

by King & Spalding on

Last week, leaders of the U.S. House Committee on Energy and Commerce (the “Committee”) sent letters to CMS and four hospital accreditation organizations, expressing concerns regarding the rigor of the accreditation survey...more

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

by 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

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

by 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

Incident reports and peer review

by Bricker & Eckler 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

Requirements for Participation Guidance for LTC Surveyors Published

by Baker Ober Health Law on

The State Operations Manual Guidance for Long Term Care Surveyors (Appendix PP), effective November 28, 2017, has undergone substantial revision. As a result of regulatory changes, the F-tags for surveys have been renumbered....more

Peer Review Not Protected: U.S. Supreme Court Will Not Disturb Florida Decision Limiting the Patient Safety and Quality...

by Baker Ober Health Law on

A multi-year discovery dispute regarding the adverse medical incident reports of a Jacksonville, Florida hospital concluded on October 2, 2017 when the United States Supreme Court denied a petition for a writ of certiorari in...more

Is Your Hospital Compliant With the Revised Joint Commission Standards for Pain Assessment and Management?

by Nossaman LLP on

On January, 1, 2018, The Joint Commission’s (“TJC”) new and revised pain assessment and management standards go into effect for TJC accredited hospitals. The changes to the standards stem from a review commenced by The Joint...more

Sixth Circuit Court Agrees with Home Healthcare Employer’s Termination of Nurse

by Seyfarth Shaw LLP on

Seyfarth Synopsis: In this case a home-care nurse complained about the quality of care her patient received from the patient’s family members. Subsequent review and inspections by the company found some “serious problems”...more

FDA Launches New Tool For Accessing Drug Adverse Event Information

by Hogan Lovells on

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D....more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

Hollywood Hills Nursing Home — Grim News

Victims of Profit? The death toll mounted again in the Broward County nursing-home disaster following Hurricane Irma. A ninth patient expired after being evacuated from The Rehabilitation Center at Hollywood Hills in the...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Top 10 Health Technology Hazards for 2017

Clinicians, engineers, safety analysts and scientists at the ECRI Institute have released a looming list of things that could go wrong with modern medical devices and technology in the marketplace....more

To the Spoiler Go the Spoils: OIG Approves Limited Product Replacement Program

by Hogan Lovells on

A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes...more

OIG Makes Monthly Update to Its Work Plan

by King & Spalding on

Last month, the HHS Office of Inspector General (OIG) announced that it would start updating its Work Plan website on a monthly basis instead of only once or twice per year. Consistent with this new initiative, the OIG...more

Better Healthcare Newsletter from Patrick Malone - August 2017

Medicine's dirty secret: tens of thousands suffer injury and death from preventable error - Each year tens of thousands of Americans are killed by medical mistakes and errors. These avoidable deaths and the many more...more

Ministers Provide Insight on the UK's Position on the Regulation of Medicines post-Brexit

by Hogan Lovells on

With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...more

Economists’ Rx for MDs’ legal wellbeing? Practice better medicine

In the battles between lawyers and doctors over malpractice lawsuits filed by patients harmed while seeking medical services, it may be worth heeding economists’ prescription for caregivers: Physicians, heal thy selves....more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

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Cybersecurity

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