Health Consumer Protection

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New California Privacy Laws

California continues to lead the way in passing new or updating existing data protection legislation. The weekly disclosure of new data breaches that involve retail and other corporations has focused the general public...more

Office for Human Research Protections Extends Comment Period for Draft Guidance

The Office for Human Research Protections (OHRP) is extending the comment period for its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft Guidance). Parties interested...more

CFPB Addresses Medical Debt Collection, Requires Consumer Reporting Agencies To Provide Accuracy Reports

On December 11, the CFPB held a field hearing on medical debt collection and how it affects consumer credit reports. In his prepared remarks, Director Cordray announced the release of a white paper focused on the specific...more

Banking and Financial Services E- Note - December 2014

In This Issue: - Congress Move to Roll Back Bank 'Push-Out' Regulation Meets Anger - NCUA Calls for Retailers to Cover Data Breach Costs - Regulators Propose 8 Biggest Banks Increase Capital...more

Health Care Update - December 2014 #4

Let’s Get to Work: OIG Releases 2015 Work Plan, Focusing on Long-Term Care and Health Reform - The U.S. Department of Health and Human Services (HHS)--Office of Inspector General (OIG) released its 2015 Work Plan (Work...more

California’s Insurance Fraud Prevention Act: 3 unsettled issues the health sector should understand

California’s Insurance Frauds Prevention Act, Ins. Code §§ 1871 et seq. (IFPA), is an unusual false claims statute. It allows “interested persons” (aka whistleblowers or relators) to file false claims lawsuits based on the...more

News from the Health Law Gurus™

Patient Medical Records Stolen from New Jersey Storage Facility – Tribeca Medical Center is notifying patients that their protected health information may be compromised. According to a privacy notice posted on Tribeca...more

Restaurant Franchisors: Prepare to Comply With New FDA Menu Labeling Rules

The U.S. Food and Drug Administration (FDA) released its final rules for menu labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive health care reform...more

Medical Billing Provider and its Former CEO Settle FTC Charges That They Misled Consumers About Collection of Personal Health Data

In an age when many of us briskly scroll through website terms and conditions and check, “I agree” without thinking, how should businesses design their websites to obtain proper authorization to access users’ sensitive...more

FDA Issues Guidance on “Patient Counseling Information”

The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R....more

The Beat Goes On: Antitrust Enforcement and Healthcare*

In one form or another, the Federal Trade Commission (FTC) has been banging the drum that there is no inconsistency between antitrust enforcement and healthcare. The latest to pick-up the drumbeat is the chair of the FTC...more

CFPB Addresses Medical Debt

The CFPB released a report that found medical debt has a significant impact on consumer credit, as 43 million Americans have overdue medical debt on their credit reports. The CFPB is concerned that the systems for incurring,...more

Just in Time for the Holidays: Another HIPAA Settlement

On December 2, 2014, the Office for Civil Rights (OCR) and Anchorage Community Mental Health Services, Inc., (ACMHS) entered into a Resolution Agreement and Corrective Action Plan (CAP) to settle alleged violations of the...more

CFPB requires credit bureaus to identify furnishers and industries with highest dispute rates and issues study of collections...

In conjunction with its field hearing today on medical debt collection, the CFPB released a study that “describes characteristics of the medical and non-medical collections tradelines on consumers’ credit reports and the...more

Recent HHS Settlement Highlights Importance of Updating HIPAA Compliance Programs

On December 8, 2014, the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) announced a resolution agreement with Anchorage Community Mental Health Services, Inc. (ACMHS). The agreement, which...more

Grand Theft PHI – Are Vendors Putting You at Risk for a HIPAA Breach?

Your vendor’s employee goes home after a long day of collecting wellness questionnaires and biometric screening results only to wake up the next day to discover that her car has been stolen from her driveway. As you can...more

Refill Reminders and the TCPA

The Telephone Consumer Protection Act (“TCPA”) presents another challenge as health care providers continue to engage patients and seek to meet Meaningful Use reminder objectives. Over the past year, there have been several...more

FDA Issues Much Anticipated Final Rules on Menu and Vending Machine Nutrition Labeling

The U.S. Food and Drug Administration (FDA) recently published the long awaited final rules on menu and vending machine nutrition labeling. The rules implement section 4205 of the Patient Protection and Affordable Care Act...more

The National Association of Insurance Commissioners Weigh in on Issues of Network Adequacy

Network adequacy—a health plan’s ability to provide timely access to a sufficient number in-network providers—has become a matter of increased scrutiny during these early years of ACA implementation; Many consumer and...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

CFPB to hold Dec.11th field hearing on medical debt collection

The CFPB has announced that it will hold a field hearing on medical debt collection in Oklahoma City, OK on December 11. The hearing will include remarks from Director Cordray and testimony from consumer groups, industry...more

Final Menu Labeling Rules Released by FDA

The U.S. Food and Drug Administration (FDA) released two final rules for menu and vending machine labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

Growing Safety Risk for Hospitals: Spiraling Medical Device Recalls

Everyone knows that the number of medical device recalls is on the rise. Here are two telling examples of the growth. In 2003 a total of 604 recalls were reported to the FDA, while last August a single manufacturer recalled...more

Connecticut Supreme Court Issues Decision That Could Expand State Law Liability in Data Breach Class Actions for Businesses...

Health care providers have not escaped the recent proliferation of data breach class actions, but plaintiffs generally have been unsuccessful in bringing claims based on the Health Insurance Portability and Accountability Act...more

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