News & Analysis as of

Medical Devices Health Care Providers

Shanghai Tightens Industry Interactions with HCPs

by Ropes & Gray LLP on

In August 2017, multiple departments of Shanghai government, led by Shanghai’s Health and Family Planning Commission (“Shanghai HFPC”), jointly issued a series of administrative rules (collectively, “Recent Shanghai Rules”)...more

20 FAQs for Telemedicine Providers in Ohio

by Foley & Lardner LLP on

The Ohio Medical Board just published new FAQs and guidance on practicing via telemedicine, addressed to Ohio physicians and physician assistants. The FAQs follow the Ohio rules for telemedicine prescribing of drugs and...more

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

Digital Currencies and Blockchain in the Medical Arena

by Knobbe Martens on

Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that...more

Impact of Value-Based Health Care on the Medical Device Industry: Three Takeaways From the Case for Transformation

by Ropes & Gray LLP on

Introduction: The Case for Transformation - In the world of fee-for-service health care, most medical devices were sold to hospitals or other health care providers for use in the diagnosis or treatment of patients. Except...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

"Sunshine" in Belgium: New Statutory Transparency Requirements for Life Sciences Companies

by Allen & Overy LLP on

On 23 June 2017, the Belgian “Sunshine Act” entered into force, requiring life sciences companies to disclose relationships with healthcare actors based in Belgium. Companies in both the pharmaceutical and medical devices...more

OIG’s Expanded Interpretation of Warranty Safe Harbor Portends Well for Value-Based Health Care

by Ropes & Gray LLP on

In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) clarified the scope of the Anti-Kickback Statute (“AKS”) warranty safe harbor (the “Warranty Safe Harbor”). In...more

Is the Dam Breaking? Over-the-Counter Hearing Aids

by BakerHostetler on

The FDA Reauthorization Act (H.R. 2430), recently signed into law by President Donald Trump, included the Over-the-Counter (OTC) Hearing Aid Act, which requires the Food and Drug Administration (FDA) to develop regulations...more

AGG Food and Drug Newsletter - August 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Healthcare Industry May Not Be Prepared For Internet of Things

by Knobbe Martens on

A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT...more

Capitol Hill Healthcare Update

by BakerHostetler on

Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the law’s beleaguered individual exchanges – after the Senate last...more

FDA Announces New Digital Health Innovation Programs

by Ropes & Gray LLP on

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the Food and Drug Administration (“FDA”) has announced new plans to streamline the development and availability of high...more

Value-based health care: fraud & abuse laws

by Ropes & Gray LLP on

Michael Lampert, Ropes & Gray health care partner, discusses fraud and abuse law application to value-based health care arrangements. __ Much has been made about how the fraud and abuse laws, which were designed in order...more

FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework

by Ropes & Gray LLP on

In his first public statement as Commissioner of the Food and Drug Administration (“FDA”) on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes. In a...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Health Alert (Australia) 12 June 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 7 June 2017 - Al Muderis v Duncan (No 3) [2017] NSWSC 726 - DEFAMATION – assessment of damage – highly respected orthopaedic...more

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems

by Knobbe Martens on

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017. The report recommends various protective actions for hospitals to take and points to...more

Eighth Circuit Court of Appeals Affirms Dismissal of TCPA Claims on Grounds of Prior Express Consent

by Stinson Leonard Street on

In Zean v. Fairview Health Services, the U.S. Court of Appeals for the Eighth Circuit recently affirmed the district court's dismissal of a putative class action complaint under the Telephone Consumer Protection Act (TCPA)....more

HHS Task Force Says Healthcare Cybersecurity is in “Critical Condition”

Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry’s cybersecurity challenges. That Task Force–a combination of public and private...more

Value-based health care: data & technology

by Ropes & Gray LLP on

Ira Parghi, Ropes & Gray health care counsel, discusses the increasing role that data and technology will play in a value-based health care world. __ There’s a lot going on when it comes to technology and health care. We...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Ransomware Imminently Expected to Target Medical Devices

by Baker Donelson on

As a wave of devastating ransomware-based attacks spread across the globe last week, it became abundantly clear that the medical industry at large was ill-prepared for the threat despite years of warnings. The virus hit...more

Health Care Provider Insights - Introductory Edition

by Wilson Elser on

Welcome to the introductory edition of Health Care Provider Insights. We are practice management consultants, providing legal and business management advice and assistance to physicians and dentists (health care...more

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