Health Consumer Protection

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Federal Court Finds That 2015 TCPA Safe Harbor Applies to Automated Flu Shot Reminders

A recent decision from a federal court in California found that a retail pharmacy’s “flu shot reminder” calls to mobile phones fall within the FCC’s TCPA safe harbor for exigent health care treatment messages. But the holding...more

Sharing Consumer Health Information? Look to HIPAA and the FTC Act

Does your business collect and share consumer health information? Check out these tips from the FTC for complying with HIPAA and the FTC Act....more

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

HHS-OCR Announces Guidance On HIPAA Compliance And Cloud Computing

On October 6, 2016, the Department of Health and Human Services Office for Civil Rights (“OCR”) issued guidance on complying with HIPAA privacy, security, and breach notification rules when using cloud computing technology...more

Hospitals Considering Merger Face Increased Uncertainty

PinnacleHealth System and Penn State Hershey Medical Center have abandoned their merger plans following a Third Circuit defeat last month. The announcement underscores the uncertainty faced by hospitals considering...more

Third Circuit Delivers Resounding Victory for FTC in Pennsylvania Hospital Merger Case

On September 27, 2016, the U.S. Court of Appeals for the Third Circuit handed the Federal Trade Commission (FTC) a significant antitrust victory by granting its request for a preliminary injunction to stay the pending merger...more

DOJ-AmEx Case Could Have Ramifications for Health Care Providers

The U.S. Department of Justice's loss to American Express sends a message to health care providers: Steering, tiering, exclusive dealing and other contractual arrangements that appear to suppress competition in one part of...more

New OIG Studies Reveal Clinical Lab Test Payment Trends and CMS’ Progress in Implementing PAMA

Last week, the OIG released two new studies analyzing what and how Medicare pays for clinical laboratory tests (“lab tests”). The first study, Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of...more

Federal Trade Commission's Pennsylvania Hospital Challenge Moves Forward: Third Circuit Halts Transaction Pending Trial Outcome

A Federal Appeals Court has sided with the FTC and preliminarily blocked the proposed merger of the largest hospitals in the Harrisburg, Pennsylvania area, and Penn State Hershey Medical Center and PinnacleHealth System. The...more

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes”

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more

FDA Proposes to Modify Good Laboratory Practice Regulations, Broaden Application and Authority

On August 24, 2016, the US Food and Drug Administration (FDA) issued a Proposed Rule on Good Laboratory Practice for Nonclinical Laboratory Studies (Proposed Rule), which broadens the application and authority of Good...more

CMS Issues Final Rule Overhauling SNF/NF Requirements of Participation

The Centers for Medicare & Medicaid Services (CMS) issued a wholesale revision to the rules governing long term care (LTC) facilities on September 28, 2016. Prompted by the changing population of nursing homes which have...more

CMS Issues Final Rule Addressing Improvements in Care, Safety and Consumer Protections for Nursing Home Residents

On September 28, 2016, CMS issued a final rule to improve the care and safety of nursing home residents in long-term care facilities. The new rules are intended to reduce unnecessary hospital readmissions and infections,...more

Better Healthcare Newsletter from Patrick Malone - October 2016

That electronic device in your palm has become more than your best friend. Half the adults around the world have become so addicted to their smart phones that wags say we are a new species: Phono sapiens. Can our phones...more

FDA Regulatory and Compliance Monthly Recap — September 2016

FDA issues final rule modifying regulations for drug establishment registration, listing requirements - The final rule, which comes nearly 10 years after changes were initially proposed, updates the regulations to...more

Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”). DPH believes that believes the proposed...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

Public Health Bills Advance

On September 30, 2016, President Obama signed into law S 1878, the Advancing Hope Act, which modifies the FDA’s priority review voucher program for rare pediatric diseases and extends the program through December 31, 2016. In...more

FTC Bureau Director Highlights Continuing Health-Related Enforcement, Homeopathic Guidance, and ROSCA at NAD Conference

Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, highlighted the agency’s enforcement priorities at the National Advertising Division’s annual conference earlier this week. Key mentions included the...more

Part I - TCPA: Regulatory - Calls By or on Behalf of the Federal Government

A number of organizations filed comments and/or reply comments regarding the National Consumer Law Center (“NCLC”)’s Petition for Reconsideration of the Broadnet Declaratory Ruling, which asks that the FCC reconsider its...more

California Clamps Down On Surprise Out-Of-Network Bills

On September 23, 2016, Governor Brown signed AB 72, California’s surprise out-of-network law. The bill protects patients who seek care at an in-network facility from balance billing by individual health care providers who are...more

California Targets Surprise Medical Bills, Follows on the Heels of New York and Florida

Governor Brown approved a new law last Friday that limits patient exposure to so-called surprise medical bills. AB 72 caps the cost-sharing obligations of patients who unexpectedly receive care from non-contracted providers...more

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

FTC Wins Key Appellate Victory in FTC v. Penn State Hershey Medical Center

The Federal Trade Commission (FTC) won a decisive victory today in its efforts to slow the record pace of health care provider consolidation, when the U.S. Court of Appeals for the Third Circuit reversed a District Court's...more

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