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Manufacturers Healthcare Reporting Requirements

Bradley Arant Boult Cummings LLP

Balancing Act: Industry Concerns Over CISA’s Proposed Cyber Incident Reporting Rule

As discussed in our previous blog post, the Cybersecurity and Infrastructure Security Agency (CISA) is proposing a significant new rule to bolster the nation’s cyber defenses through mandatory incident reporting. While...more

Steptoe & Johnson PLLC

Hazard Alert! Don’t Ignore OSHA’s Updated Electronic Submission Requirements for Employers

Steptoe & Johnson PLLC on

Effective January 1, 2024, the Occupational Safety and Health Administration’s (OSHA) new record-keeping rule will now require employers with 100 or more workers in OSHA’s “highest hazard” industries to electronically file...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Mintz - Health Care Viewpoints

Sunshine Act Expands to Advance Practice Nurses and Physician Assistants

Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more

Robinson+Cole Data Privacy + Security Insider

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

Robinson & Cole LLP

Connecticut Legislature Reduces Mandatory Reporting of Payments to APRNs

Robinson & Cole LLP on

On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more

Cooley LLP

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

Cooley LLP on

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Latham & Watkins LLP

Applicable Manufacturers Face June 30th Deadline for Sunshine Act Reporting

Latham & Watkins LLP on

CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more

King & Spalding

CMS Delays Open Payments Data Submission Deadline, Announces Registration Process; Requires Manufacturers and GPOs to Report...

King & Spalding on

On Friday, February 7, 2014, the Centers for Medicare and Medicaid Services (CMS) announced that Open Payments registration is scheduled to begin on Tuesday, February 18, 2014 for applicable manufacturers and applicable group...more

Mintz - Health Care Viewpoints

The Countdown Begins – Sunshine Act Data Collection

With the August 1 deadline for data collection under the Physician Payments Sunshine Act (the “Act”) looming, CMS recently released two mobile applications (“Apps”) to help physicians and industry track payments and transfers...more

Perkins Coie

Getting Ready For The Physician Payment ‘Sunshine’ Rule

Perkins Coie on

Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more

Morgan Lewis

Final Sunshine Act Arrives: Now the Hard Part

Morgan Lewis on

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

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