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Automated Drug Dispensing

Despite its plain text, the California Board of Pharmacy (the “BoP”) has adopted an interpretation of state statute requiring stocked removable pockets for automated drug dispensing systems (“ADDS”) to be transported to and...more

A Lifelong Commitment: FDA Releases Postmarket Guidance on Cybersecurity Risk Management for Medical Device Manufacturers

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more

Keeping it Legal: Managing FDA Compliance for Consumer-Generated Content

Social technology platforms allow manufacturers to leverage consumer-generated content about their products (“CGC”) more easily than ever before. Such CGC generally takes the form of written testimonials and product reviews...more

Ancillary Joint Ventures Involving Taxable and Tax-Exempt Health Care Entities: Addressing the Chilling Effect of IRS Inaction

Tax-exempt health care systems facing growing operating costs and falling revenues frequently explore creation of ancillary joint ventures (AJVs) as vehicles to raise capital, share risk, expand coverage, and provide care...more

Omnibus Final Rule Issued on HIPAA/HITECH Act: Significant Changes for ‘Business Associates’

On January 25, 2013, the Department of Health and Human Services published the much-anticipated Omnibus Final Rule (the “Final Rule”), which, with respect to business associates and their subcontractors, conforms HIPAA’s...more

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