Rhode Island Hospital Reaches Settlement with Massachusetts AG to Resolve Data Security Allegations

Last week, Women & Infants Hospital of Rhode Island (“W&I”) reached a settlement with the Massachusetts Attorney General to resolve allegations that W&I failed to adequately protect personal data stored on unencrypted backup tapes, violating both state and federal data security laws.  W&I has agreed to enhance its data security compliance program and to pay a total of $150,000. Continue reading

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Filed under Government Enforcement, Health Information Privacy, Health IT, HIPAA, HITECH Act, Privacy and Security

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors and packers that use social media and the internet to promote FDA-approved products.  The FDA has made the PowerPoint and webinar Q&As publicly available for review.  Specifically, as we informed you here and here, the FDA issued the following three draft social media guidance documents:

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Filed under FDA, FDA Draft Guidance, Social Media

CMS Releases New Resources, Schedules Teleconference for Sunshine Review and Dispute Process

As we informed you last week, the Open Payments review, dispute and correction process started today and will continue through September 11, 2014.  This is the process that allows physicians and teaching hospitals to review and dispute information regarding payments and other transfers of value that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) recently reported to CMS, before CMS publicly discloses this information by September 30, 2014.

To assist with this process, CMS released an updated Open Payments User Guide to provide a comprehensive overview of the Open Payments system and requirements.  CMS also released the following Quick Reference Guides:

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Filed under Federal Transparency

CMS Announces Dates for Sunshine Payment Review, Dispute & Correction Process

The Centers for Medicare & Medicaid Services (CMS) announced today that the Open Payments review, dispute and correction process will begin on Monday, July 14, 2014 and continue through September 11, 2014.  Under the Sunshine Act final rule, physicians and teaching hospitals have the ability to review and dispute payments and other transfers of value that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) recently reported to CMS, before CMS publicly discloses this information by September 30, 2014.  Specifically, physicians and teaching hospitals can review and dispute payments from July 14 through August 27, and manufacturers and GPOs have an additional 15 days, until September 11, to submit corrections. Registration by physicians and teaching hospitals in the CMS Enterprise Portal and Open Payments system is voluntary, but must be completed if physicians wish to review and dispute any information before public disclosure by CMS.  Because this registration process can take some time, physicians and teaching hospitals are encouraged to start the process as soon as possible.

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The 3D Printing Revolution Meets Health Care

On June 17, Cooley LLP and NYC Health Business Leaders co-hosted “The 3D Printing Revolution Meets Health Care,” a cutting-edge event addressing the state of the 3D printing (3DP) revolution in health care. The event defined the current and future market, described the business, operational, legal and regulatory issues confronting the industry and discussed the next generation of technology. Already used with prosthetics, dental implants, and orthotics, health care is one of the fastest growing segments of the 3DP industry. The event truly exemplified the intersection of the health care, life sciences and technology industries. Live demonstrations followed the expert panelists. Speakers included: Land Grant, Founder and CEO of 3DP Media, Inc.; Zack Schildhorn, VP at Lux Capital; and John Meckler, Portfolio Manager at 3D Printing and Technology Fund in Manhattan. The live demonstrations were provided by Jerry Castanos of 3D Heights and Anan Natarajan of LayerWise.

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Filed under 3D Printing, 3DP, Health Care, Medical Devices, Technology

FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use.  All of the documents are available through the FDA’s website.  Tuesday’s issuances were part of the FDA’s continued implementation of the Drug Quality and Security Act (DQSA), enacted in 2013 in response to a 2012 outbreak of fungal meningitis that was traced back to a compounding pharmacy.  Among other things, Title I of the DQSA gave the FDA stronger statutory authority to regulate certain compounding pharmacies, and removed provisions previously found unconstitutional.  Specifically, the FDA released the following documents:

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Filed under FDA, FDA Draft Guidance, FDA Final Guidance

LITIGATION ROUND-UP

Litigation Round-up

Settlements & Resolutions

GlaxoSmithKline (GSK) agreed to pay $105 million to resolve allegations that it illegally marketed its asthma drug Advair and its antidepressants Paxil and Wellbutrin for uses not approved by the US Food and Drug Administration (FDA) in violation of state consumer protection laws.  The multi-state settlement included 44 states and the District of Columbia.  In a separate settlement with the West Virginia Attorney General, GSK also agreed to pay $22 million to settle allegations that the company engaged in an illegal marketing campaign to promote diabetic drugs Avandia, Avandamet and Avandaryl.

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Filed under Government Enforcement