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

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Updates to Pennsylvania’s Medical Marijuana Program

by Tucker Arensberg, P.C. on

On April 26, Pennsylvania’s Secretary of Health Dr. Karen Murphy provided an update on the application review process for contending grower/processors and dispensaries. The Department of Health (DOH) has received over 500...more

Health Update - April 2017

CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations - On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more

How Will the Trump Administration Impact Healthcare Litigation?

Editor's Note: In a dramatic conclusion to the heated debate surrounding the American Health Care Act (AHCA), the bill was withdrawn after it became clear that House leadership did not have enough votes to pass it. There is...more

St. Jude Medical On Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the...more

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition

by Jones Day on

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more

Pennsylvania Releases Temporary Regulations for Physicians

by Tucker Arensberg, P.C. on

On April 11, the Pennsylvania Department of Health (DOH) released Practitioner Temporary Regulations for physicians and practitioners (those physicians, pharmacists, physician assistants and certified registered nurse...more

FDA authorizes first direct-to-consumer genetic test panel for predisposition to Alzheimer's disease and other serious disorders

by DLA Piper on

The FDA has announced its decision to grant a de novo application submitted by 23andMe for the company's direct-to-consumer (DTC) Personal Genome Service Genetic Health Risk ("GHR") tests. The GHR test panel currently...more

Politics, Medicine and Progress

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Assisted Living Facilities: Preparation for Regulatory Changes

by Williams Mullen on

The Virginia Board of Social Services (Board) is working on a comprehensive overhaul of the regulations governing assisted living facilities. The revised regulations are at the final regulations stage....more

D.C. District Court Upholds CMS’s Predicate Fact Three-Year Reopening Limitation

by King & Spalding on

On March 10, 2017, Judge John Bates of the U.S. District Court for the District of Columbia upheld CMS’s three-year cost report reopening limitation, as applied to “predicate fact” determinations. The regulation at issue is...more

AbbVie’s Humira is the first to receive FDA approval for fingernail psoriasis

by Goodwin on

Today, AbbVie announced that the F.D.A. approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis....more

FDA Approves Genentech’s Ocrevus (ocrelizumab)

by Goodwin on

FDA announced today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”). Ocrevus is the first drug...more

OIG Approves Free Lodging and Meals Under "Promotes Access to Care" Exception to Beneficiary Inducement CMP

by Baker Ober Health Law on

In Advisory Opinion 17-01, published March 10, 2017, the Department of Health and Human Services, Office of Inspector General (OIG) approved an academic medical center's proposal to provide free or reduced-cost lodging and...more

Certain Medical Devices Exempted from 510(k) Requirements

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

by Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Federal Health Care Leaders Write Governors About New Direction for Medicaid

While much of the attention related to health care this week is focused on our nation’s capital, all 50 state governors have received a letter from recently confirmed U.S. Health & Human Services Secretary Tom Price and...more

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

by Hogan Lovells on

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

Proof by Proxy in FCA Suits? District Court Says It Depends

by Morgan Lewis on

Admissibility of statistical sampling to prove liability in FCA suit is fact dependent. In a February 14, 2017 decision, the Fourth Circuit declined to rule on the question of whether statistical sampling can be used to...more

Fourth Circuit Takes a Pass on Statistical Sampling, Finds DOJ's Settlement Veto Authority Unreviewable

by Bass, Berry & Sims PLC on

After granting the relators’ petition for an interlocutory review of the district court’s rejection of the use of statistical sampling to establish FCA liability, the Fourth Circuit ultimately declined to reach that issue in...more

Sportbrain Sues Smartwatch Manufacturers, PTAB institutes IPR against Patent-in-Suit

Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent...more

ERISA: Winning Tactic on Summary Judgment to Prove Claimant Received the Policy: Get Key Evidence into the Administrative Record

You know that to apply an exclusion in a policy, the claims administrator must show that the claimant received the policy. But what happens when the claimant submits a declaration disputing your proof that she received...more

HHS Finalizes Appeals Backlog Rule in Wake of Judicial Order

by Polsinelli on

The U.S. Department of Health and Human Services (HHS) released a Final Rule aimed at reducing and eventually eliminating the backlog of more than 650,000 claims currently awaiting adjudication by an administrative law judge...more

Relocation of the EU Medicines Agency: Italy

by Hogan Lovells on

The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more

WPI Insider Briefing: New President, New Congress, New Direction in Workplace Policy

by Littler on

President Donald J. Trump was sworn into office on January 20, 2017, ushering in a new balance of power in Washington and what is expected to be a dramatically different era of workplace policy. On his first day in office,...more

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