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Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

FDA Approves Blood Test for Concussion

by Knobbe Martens on

The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway. According to the press release, Banyan BTI is...more

Colorado Court of Appeals Issues Needed Guidance on Physician Non-Compete Agreements

The inclusion of a non-compete agreement, or covenant not to compete, is frequently one of the most anxiety-producing issues in physician employment contracting on the part of both the physician and the employer. This has...more

Class III Hospital Permits – Efficient Drug Management May Become a Reality

At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their...more

HIMSS18: What We Learned in Vegas Doesn’t Have to Stay in Vegas

Complex. Hard. Humbling. These are the descriptors former Google CEO Eric Schmidt used last week at the HIMSS 2018 Annual Conference in Las Vegas to describe the work to be done in health information technology (HIT). ...more

473,807 Patient Records Compromised in January, 2018—83 Percent Caused by Hacking Incidents

The recently released Protenus Healthcare Breach Barometer report notes that in January, 2018, at least 473,807 patient records were compromised in 37 breaches reported to the Office for Civil Rights. ...more

Changes in Federal Enforcement Cases and the Stark Law May Benefit Health Care Providers

by Ruder Ware on

Some recent changes in federal law and in federal agency interpretation of federal law may both clarify and relieve some regulatory obligations of health care providers. Lessening Dependence on Federal Agency...more

Legal Black Holes Proliferate After Stephen Hawking’s Death – Massachusetts Allows Somewhat Limited Innovator Liability

by Reed Smith on

Stephen Hawking may have been the smartest guy in the world, even though he believed that “People who boast about their I.Q. are losers.” Hawking is best known for his work on black holes. As used in physics, a black hole...more

5 Key Takeaways on Top Surgical Specialty Investments

by McGuireWoods LLP on

The next in our series of posts sharing key takeaways from panels at the Healthcare & Life Sciences Private Equity and Lending Conference focuses on investing in surgical specialty practices. *** Investment and...more

D.C. Circuit Unwinds 2015 FCC TCPA Ruling: An Overview

by Balch & Bingham LLP on

In a watershed case, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) unwound key components of the controversial 2015 ruling by the Federal Communications Commission (FCC or Commission)...more

Employment Law This Week®: NYC’s #MeToo Legislation, Title VII & Gender Identity, False Claims Act Lawsuit, Flu Shot Policy

by Epstein Becker & Green on

We invite you to view Employment Law This Week® - a weekly rundown of the latest news in the field, brought to you by Epstein Becker Green. We look at the latest trends, important court decisions, and new developments that...more

Verizon Protected Health Information Data Breach Report Concludes that Insiders Are Greatest Threat to Health Care Entities

Verizon recently issued its Protected Health Information (PHI) Data Breach Report, which is always an interesting read. Not surprisingly, Verizon’s report concludes that based upon analysis of 1,360 security incidents...more

Alston & Bird Healthcare Week In Review

by Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Will High Court Provide Clarity On 'Clear Evidence'?

by Morrison & Foerster LLP on

The U.S. Supreme Court may soon revisit one of its seminal decisions defining products liability law for pharmaceutical manufacturers. That decision — Wyeth v. Levine — addressed whether a branded manufacturer could be held...more

The Best Wisconsin Law Decision We’ve Ever Seen, Affirmed

by Reed Smith on

The district judge in the In re Zimmer Nexgen Knee Implant Products Liability Litigation MDL issued a summary judgment order in October 2016 that we called “the best Wisconsin law decision we have ever seen.” What was the...more

Recent Healthcare Fraud Suit Puts Private Equity Industry on Notice as to Potential Liability for Portfolio Company Conduct

by White and Williams LLP on

In February, the Department of Justice (DOJ) intervened in a False Claims Act case alleging healthcare fraud, a common enough event. The case in question, originally began in 2015 as a whistleblower case brought by two...more

New Jersey Congressman Calls for a Hearing on the Proposed Cigna/Express Scripts Merger

Recently, Cigna announced its plan to purchase pharmacy benefit manager (“PBM”) Express Scripts. In a March 14, 2018 letter to the chair of the House Committee on Energy and Commerce, Gregory Walden (R-Oregon), Congressman...more

Recent Anti-Kickback Cases Emphasize Government Scrutiny of Speaker’s Bureaus and Lavish Meals Funded by Pharmaceutical and Device...

The Department of Justice (DOJ) recently resolved two health care fraud cases – one criminal and one civil – that demonstrate the government’s continued scrutiny of lavish meals and “speaker’s bureaus” sponsored by...more

New York Settles EmblemHealth Breach for $575,000

The recent $575,000 settlement with EmblemHealth signals a push from AG Schneiderman “for stronger security laws and hold[ing] businesses accountable for protecting their customers’ personal data.” Noting New York’s “weak and...more

Digital Health: CE marking of medical devices

by Hogan Lovells on

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more

Health Care : Helpful Hints – March 2018

by Burr & Forman on

Alabama Data Breach Notification Act - On March 1, 2018, the Alabama Senate voted for passage of Senate Bill 318,the Alabama Data Breach Notification Act, by a vote of 24-0. The bill is now being considered by the Alabama...more

CMS releases new and updated tips on billing for various services

by Bricker & Eckler LLP on

On February 22, 2018, the Centers for Medicare & Medicaid Services (CMS) released several new and revised provider compliance tip sheets as part of its monthly update to the Medicare Learning Network (MLN) homepage....more

DOH Finalizes Temporary Regulations For Clinical Registrants And Academic Clinical Research Centers

by Cozen O'Connor on

The Pennsylvania Department of Health (DOH) published the much anticipated final version of the temporary regulations under the Medical Marijuana Act applicable to Clinical Registrants and Academic Clinical Research Centers...more

K&L Gates Triage: The Opioid Epidemic: Federal and State Requirements on Medication-Assisted Treatment for Substance Abuse...

by K&L Gates LLP on

In the sixth episode of our series on the national opioid crisis, Lauren Perry discusses some of the legal obligations for providers who prescribe controlled substances as treatment for substance abuse disorders....more

Florida Clinic License Exemptions Subject to Change

Holders of Florida healthcare clinic license exemptions take note. Exemption certificates, which currently bear no expiration date, will expire every two years if a bill recently passed by the Florida Legislature becomes law....more

Bipartisan Budget Act Revises Stark Law, Increases Penalties for AKS and CMP Law Violations, and Expands Telehealth Coverage

On February 9, 2018, Congress passed the Bipartisan Budget Act of 2018 (the Act), which included a number of important health law provisions.. ...more

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