Wednesday, August 20, 2014

FDA Issues Guidance for Drug & Device
Companies’ Social Media Interactions

In June, the U.S. Food and Drug Administration issued two draft guidance documents for the pharmaceutical and medical device industries related to social media. The guidance is part of an asserted effort by FDA to provide more clarity regarding how drug and device manufacturers may appropriately communicate through Internet platforms.

The first document, Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, addresses advertising and promotional communications concerning prescription drugs and medical devices on sites where character space is limited, such as Twitter and sponsored search engine results. The guidance specifies, among other things, that each “tweet” must include both benefits and risks of the promoted drug and should include a hyperlink to a more comprehensive list of risks and side effects.

Wednesday, August 13, 2014

Upcoming HIPAA Deadlines for
Employer-Sponsored Group Health Plans

September 22, 2014, Deadline for Certain Business Associate Agreements
The Health Insurance Portability and Accountability Act (“HIPAA”) requires a covered entity, including an employer-sponsored group health plan subject to HIPAA, to enter into a HIPAA-compliant business associate agreement with each of the covered entity’s business associates (i.e., entities that perform services for the health plan and have access to protected health information). In 2013, the Department of Health and Human Services (“HHS”) issued final regulations modifying HIPAA. The regulations required HIPAA-covered entities to amend or restate their business associate agreements to reflect the new regulations.