News & Analysis as of

Health Information Technologies

Vermont’s New Telemedicine Law Expands Insurance Coverage, Bans Recording

by Foley & Lardner LLP on

Vermont health care providers and patients can now enjoy a revamped, and significantly improved, telehealth commercial insurance coverage law. Vermont Governor Phil Scott signed S. 50 into law on June 7, 2017, expanding...more

The Changing Telehealth Landscape

by Burr & Forman on

When healthcare providers and information technology (IT) appear together in the news, it is often for less than positive reasons. The cyber security issues that have plagued everyone have not left physicians and hospitals...more

Senate Proposes Expanded Use of Telehealth

On May 18, 2017, the Senate Finance Committee voted to move forward a bill entitled the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S870), which would increase access to...more

Cybersecurity Task Force Issues Report on Improving Cybersecurity in the Health Care Industry

by Dorsey & Whitney LLP on

The Cybersecurity Act of 2015 established the Health Care Industry Cybersecurity Task Force to respond to severe cyber-attacks within the rapidly-expanding information technology (“IT”) aspect of health care. Section 405(c)...more

Measures of success: How value-based pricing may change the pharmaceutical industry

by Hogan Lovells on

Adoption of value-based pricing, where drug prices are linked to real-world outcomes rather than on a per-pill or per-treatment basis, will have a profound impact on the pharmaceutical industry. And with the Centers for...more

Measures of success: How value-based pricing may change the pharmaceutical industry

by Hogan Lovells on

Hogan Lovells partner Alice Valder Curran teams up with Robert Spurr of Novartis to outline the challenges and share potential solutions to consider when entering into value-based pricing arrangements. Adoption of...more

Rx IP Update - May 2017

by Smart & Biggar on

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

Philips Buys RespirTech for Undisclosed Amount

by Knobbe Martens on

Dutch conglomerate Philips recently announced that it will purchase Respiratory Technologies Inc. (RespirTech). According to its website, RespirTech describes itself as a St. Paul, Minnesota-based provider of inCourage vests,...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

Class Action Initiated Against Telehealth Provider for Disclosure of Sensitive Information

A class action was filed in Fort Lauderdale, Florida this week against a national telehealth provider, MDLive Inc. (MDLive) for its mobile app’s alleged secret capture of screenshots containing sensitive patient information...more

Major League Baseball Wearable Tech Experiment Raises Athlete Privacy Issues

by King & Spalding on

On March 6, 2017, Major League Baseball (“MLB”) announced that it has officially approved a wearable biometric monitoring device (the “Device”) for in-game use by athletes. Created by WHOOP Inc. (“WHOOP”), the Device is the...more

What's "Hidden" in the 21st Century Cures Act for Health Care Entities

by Nilan Johnson Lewis PA on

The 21st Century Cures Act (Cures) was signed into law December 13, 2016. While the primary focus of the 996-page Act centered on biomedical innovation, several components of Cures have significant implications for health...more

42 C.F.R. Part 2 Final Rule Is Officially Delayed … Can Comments to HHS and OMB Fix It?

by Davis Wright Tremaine LLP on

On January 18, 2017, the U.S. Department of Health and Human Services (HHS) published a final rule amending the Confidentiality of Substance Use Disorder Patient Records rule at 42 C.F.R. Part 2. Yesterday, HHS delayed the...more

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

EEOC issues guidance on new wellness notice mandated for 2017

by Thompson Coburn LLP on

Effective as of the first day of the plan year that began on January 1, 2017, or after, employers maintaining wellness programs that collect employee health information must satisfy a new notice requirement. The EEOC has...more

The 21st Century Cures Act

by Baker Ober Health Law on

Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more

21st Century Cures Act: Key Provisions of Interest to Drug/Device Clients

by Reed Smith on

Included in the many provisions contained in the 21st Century Cures Act are ones addressing drug, device, and biologic development and approval. Topics include the use of “real world evidence” in regulatory approvals, drug...more

Rx IP Update - December 2016

by Smart & Biggar on

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

21st Century Cures Act - HIPAA & Other Privacy Considerations

by Bass, Berry & Sims PLC on

On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more

21st Century Cures Act – Provisions Relating to Digital Health

by Ropes & Gray LLP on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

Medicare, Medicaid Payment Policies, Fraud Authorities Enacted as Part of 21st Century Cures Act

by Reed Smith on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). While much of the focus has been on policies intended to accelerate drug and device development and approval, the Cures Act also...more

2016 Health IT Leadership Summit Insights

by Arnall Golden Gregory LLP on

On December 7, 2016, lawyers from Arnall Golden Gregory LLP’s Healthcare Technology team attended the annual Health IT Leadership Summit. While there, we noted several overarching themes. At the forefront were the topics of...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

by Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Trump’s Impact on Digital Health: An Analytic Framework for Evaluating the Changing Landscape

by McDermott Will & Emery on

The promise of health care reform by the incoming administration will result in significant changes; but understanding how those changes may flow through to digital health industry requires an analytic framework that...more

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