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Medical Devices Health Care Providers

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

Ten Things Investors Need to Know About Value-Based Healthcare

by Ropes & Gray LLP on

This article highlights key business and legal issues related to value-based healthcare for investors considering opportunities in the healthcare industry. 1. Value-Based Arrangements Are Here to Stay Value-based...more

Recommendations for Medical Device Manufacturers

by Ropes & Gray LLP on

The U.S. health care system is in the midst of a fundamental shift, away from traditional fee-for-service models that reward providers based upon the volume of services provided to patients, and toward value-based care...more

Health Alert (Australia) May 1, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 21 April 2017 - ILS Rehab Pty Ltd v Josephine Borg (as administrator of the estate of the late Damien Robert Borg) [2017] NSWSC 442...more

Healthcare Advisory: HHS Announces First Settlement with a Wireless Health Services Provider

by Sherman & Howard L.L.C. on

On April 24, 2017, the Department of Health and Human Services, Office of Civil Rights (“OCR”), announced its first settlement with a wireless health services provider, CardioNet, Inc., for alleged violations of the Health...more

Health Care E-Note - April 2017

by Burr & Forman on

An often overlooked and under publicized provision of the False Claims Act (“FCA”) is the retaliatory discharge prohibition. This is probably because retaliatory discharge claims do not grab headlines by winning multimillion...more

Health Alert (Australia) April 10, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 5 April 2017 - Reckitt Benckiser (Australia) Pty Ltd v Australian Competition and Consumer Commission [2017] HCASL 86 - The High...more

A Chinese healthcare boom

by Hogan Lovells on

Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Congressional Hypocrisy — Taking away your rights

As a part of the recent speed racing bills through Congress, they have put up HR 1215. Quite erroneously, they have titled it: “Protecting Access to Care Act of 2017”. A read of the act’s text quickly tells any objective...more

Medical Device Malware Medjack.3 Poses Threat to Hospitals

Medjack is a form of malware that was specifically developed to attack medical devices, such as heart monitors, CT and MRI machines, insulin pumps and PAC systems....more

Capitol Hill Healthcare Update

by BakerHostetler on

Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...more

Alert: 2016 Round-Up: Key Decisions Affecting Connecticut Health Care Providers

by Pullman & Comley, LLC on

Connecticut state and federal courts faced a number of significant health care issues last year. We have summarized those cases that we think are particularly relevant to Connecticut hospitals, group practices and individual...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Speaker Paul Ryan last week set a deadline of the end of March for repealing most of the Affordable Care Act (ACA), as other Republican leaders and conservative rank-and-file lawmakers advocated competing policy...more

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