Health Consumer Protection

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After New York, Florida Curbs Surprise Bills for Emergency and Out-of-Network Services

It is generally understood that if a managed care member utilizes the services of a non-participating provider, the member could incur significant out of pocket expenses. However, there are instances where a member may...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

Wyoming Medical Center victim of phishing scheme affecting 3,184 patients

Phishing incidents in February that may have compromised the data of 3,184 patients, including their names, dates of birth, medical record and account numbers, dates of service and medical information is causing Wyoming...more

Spring Showers Bring HIPAA Breaches

OCR has announced several recent settlement agreements to resolve violations of the Health Insurance Portability and Accountability Act (“HIPAA”). These settlement amounts range from $25,000 to $3.9 million dollars and...more

OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA)...more

Will Congress vaporize proposals to curb tobacco use, protect kids’ health?

Just days after federal health officials warned about teen-agers’ increasing use of e-cigarettes (vaping) and hookahs, members of a House committee have approved a legislative move that shields vaping manufacturers from...more

Department of Health and Human Services Cracks Down on Vendor Oversight in Recent Hospital Settlements

From the rise in ransomware attacks to inadvertent disclosure of information by subcontractors, the health services industry is reminded that a potential consequence of a data breach is the threat of a regulatory enforcement...more

Health Care E-Note - April 2016

Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurses, technicians, staff, management,...more

FTC Releases "Cheat Sheet" for Developing a Secure Mobile Health Application

The Federal Trade Commission (FTC), in partnership with other federal agencies, has released an online tool that provides developers legal guidance for the creation of mobile health applications (apps). Companies that are...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

NY Hospital to Pay $2.2 Million for Allowing TV Crew to Videotape Dying Patient

On the ABC television series “NY Med,” doctors from New York-Presbyterian Hospital (NYP) are profiled as they perform medical procedures. However, in an effort to keep it “real,” the show’s crew has landed the hospital in hot...more

AFFs, BPs, ONJ: Understanding Alphabet Soup of Osteoporosis Treatment

The American Society for Bone and Mineral Research recently reassessed the efficacy of bisphosphonate, long hailed as a wonder drug for patients with osteoporosis, and its risk factors. Through the course of two clinical...more

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more

Settle or Fight FDA/DOJ Off-Label Use Allegations? WSJ Editorial Looks at Vascular Solutions Trial Win and Asks What's Next?

In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment”...more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Regulators Offer Guidance on Privacy and Security for Health App Developers

This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

How to Prepare for the Next Round of HIPAA Audits

Nearly two years after the Office of Civil Rights (“OCR”) first announced its preparation for another round of HIPAA audits, Phase II of OCR’s HIPAA audit program is finally underway. On March 21, OCR began emailing...more

Proposed Changes to the Part 2 Regulations: Another Example of Necessary Flexibility in the Wake of Changes to Health Care...

On February 9, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations governing...more

A New Tool for Health App Developers to Navigate a Crowded Regulatory Field

As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more

Heater-Cooler Devices Linked to Infections

Heater-cooler devices are used during cardiothoracic surgeries, and other medical and surgical procedures to warm or cool a patient. They include water tanks that provide temperature-controlled water to external heat...more

You Can Pay Now or You Will Pay Later: FDA Issues a Warning Letter to a Pharmaceutical Company for a Misleading Patient Co-Pay...

On March 29, 2016, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to a pharmaceutical company for a patient co-pay assistance voucher that failed to include risk...more

SOS Answered: New Guidance on HIPAA for App Developers

Amidst criticism that the Health Insurance Portability and Accountability Act (“HIPAA”) lags behind technological innovation, the Office for Civil Rights (“OCR”) released new guidance to aid app developers in determining how...more

State AGs Upping the Ante on Health (and Other) Information Data Incidents – Expect Increased Enforcement Actions

State attorneys general (AGs) continue to emerge as major regulators of privacy, and increasingly, with respect to compromises of health-related data. Businesses concerned with U.S. customer or employee data have long...more

OCR Announces Beginning of 2016 HIPAA Phase 2 Audit Program

The OCR recently announced the beginning of the next phase of the HIPAA Privacy, Security, and Breach Notification Audit Program and indicated that it will review the policies and procedures implemented by covered entities...more

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