FDA Continues Enforcement Against Internet Marketing of Unapproved and Misbranded Drugs

EvaPharmacy recently received a Warning Letter from the United States Food and Drug Administration (“FDA”), Office of Drug Security, Integrity and Recalls regarding products available for sale to consumers in the United States on its websites.  The FDA requested that EvaPharmacy take prompt action and notify the FDA within ten […]

Electronic Submissions Now Available for OIG Voluntary Disclosures

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released an on-line Provider Self-Disclosure Protocol (“Protocol”) submission form for individuals and entities that seek to disclose to the OIG potential violations of criminal, civil, or administrative law governing health care programs for which exclusion or […]

HIPAA Settlement Alert: WellPoint, Inc. Agrees to Pay $1.7 Million

On July 11, 2013, WellPoint, Inc. (“WellPoint”) entered into a Resolution Agreement (the “Agreement”) with the U.S. Department of Health and Human Services (“HHS”) to pay $1,700,000 to settle alleged privacy and security violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  The Agreement does not contain […]

Report to Congress Shows Continuing Trend of Health IT Adoption

As our world has become increasingly paperless in recent years, the health industry has followed suit.  One illustration of this trend is the growing adoption of health IT by health care professionals, and in particular, the implementation of electronic health record (“EHR”) systems.  This transition was largely due to the […]

Regulatory Uncertainty as FDA Draft Guidance on Mobile Medical Applications Reaches its Two-Year Anniversary

Many see great promise for patients and physicians utilizing mobile devices in health care. Growth of so-called “mhealth” has been fueled by faster, more ubiquitous technology, decreasing costs, and more user-friendly applications. However, regulatory uncertainty remains a barrier to the adoption of mobile health technology.  Two years following the FDA’s […]

FDA Issues Draft Guidance on Reporting Adverse Events for Medical Device Manufacturers

The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers.  Written comments may be submitted by mail or electronically to the FDA within 90 days.  When finalized, the guidance will supercede the 1997 guidance document with the […]

No Relief in Minnesota from Reporting Obligations

On June 24, 2013, the Minnesota Board of Pharmacy posted a letter to pharmaceutical manufacturers and drug wholesalers informing them that the Board’s request to the Minnesota legislature to repeal Minnesota Stat. §151.47(1)(f) did not occur. Rather, the Minnesota legislature modified the statute related to reporting obligations. The Minnesota Board […]