News & Analysis as of

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

The regulation of cosmetic interventions in the UK: toothless rhetoric or industry overhaul?

This Reed Smith client alert looks at the UK government’s response to the independent review of the regulation of cosmetic interventions in the UK. The key issues In recent years, cosmetic procedures have become widely...more

Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the...more

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

Newest Published Literature Latest to Slam Stryker Rejuvenate Failures

Recently published literature in the Journal of Bone and Joint Surgery draws the conclusion that the short-term, high rate of corrosion-related revision with Rejuvenate modular neck implants is “striking.”...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

Intuitive Surgical Sued by Shareholders Over Withheld Complications

Shareholders have sued the maker of a surgical robot claiming the company has “grossly underreported” injuries and deaths attributed to the da Vinci....more

Tri-Agency Health IT Report Issued

Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework...more

Best Practices For Laser-Assisted Cataract Surgery

A femtosecond (FS) laser is exciting new technology, but it requires consideration of some important governance and compliance issues. Best practices require the surgeon and the facility (ASC or Hospital) to identify covered...more

Recent Developments in Medical Monitoring Case Law (2013-2014)

Over the last 30 years, state and federal courts have grappled with how best to address claims filed by plaintiffs who do not currently suffer from an actual injury or illness, but rather seek damages for their risk of...more

New York Refines When Medical Monitoring Damages Are Available

Last December, in Caronia v. Philip Morris USA, Inc., 2013 N.Y. Slip Op. 08372, 2013 WL 6589454, New York’s highest court declined to create a stand-alone medical monitoring tort for a smoker who sought damages for the...more

Chance to Comment on Future of DMEPOS Payments

CMS recently took the unusual step of issuing an Advance Notice of Proposed Rulemaking (ANPR) regarding changes to Medicare payment methodologies for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)...more

A Brief Overview of the Case Law Regarding "Failure to Train" Claims - And Its Implications for Medical Device Manufacturers

In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations...more

DMEPOS Competitive Bidding Program: CMS Begins to Move Toward Nationwide Implementation and Seeks Public Comments Regarding...

The Centers for Medicare & Medicaid Services ("CMS") recently announced that the agency is seeking public comments as it moves toward nationwide implementation of the Medicare Durable Equipment, Prosthetics, Orthotics, and...more

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

China Introduces New Health Care Sector Anti-Corruption Regulations

China Introduces New Health Care Sector Anti-Corruption Regulations As part of a concerted effort to tackle systemic commercial bribery in the country’s health care sector, China’s National Health and Family Planning...more

Health Law Alert: OIG Issues Special Fraud Alert on Physician-Owned Distributorships

On March 26, 2013, the Department of Health & Human Services Office of Inspector General (OIG) issued its latest in a line of “Special Fraud Alerts” that address the application of the Federal anti-kickback statute to...more

The Healthcare Industry And Chief Compliance Officers

The healthcare industry has been an innovative leader in developing compliance tools and strategies. They have come by it honestly – prosecutors and HHS-OIG have been pounding on pharmaceutical companies, medical device...more

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more

More Open Questions About Open Payments Under the Sunshine Act

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the...more

U.S. Access Board Advisory Committee's Recommendations for ADA-Accessible Medical Diagnostic Equipment: Implications for Health...

For the past several years, the health care community has been not only at the center of vigorous policy debates about the method of health care delivery in this country, but also in the crosshairs of agencies charged with...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - This Week’s Hearings: - Wednesday, January 15: The House Committee on Veterans’ Affairs will hold a hearing titled “Vendors in the OR- VA’s Failed Oversight of Surgical Implants.” The House...more

Joint Commission Standards Updates for 2014

For 2014, the Joint Commission approved standards changes for hospitals, critical access hospitals, and others concerning medication management and provision of diagnostic imaging services. The Joint Commission also revised...more

TVM Update: J&J Officials May Have Intentionally Destroyed Ethicon Vaginal Mesh Documents

Officials at Johnson & Johnson’s Ethicon division are currently facing serious allegations that they intentionally destroyed important documents that had been order to be preserved as evidence for thousands of vaginal mesh...more

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

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