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Results: 11-20 of 2,785

FDA issues final guidance documents on medical device data systems and medical mobile apps

  • Barnes & Thornburg LLP
  • -
  • USA
  • -
  • February 23 2015

The FDA recently issued two final guidance documents signaling its intention either not to regulate, or to give minimal oversight, to two categories

Setting the stage for value based payments and nationwide interoperability of electronic health data

  • Dickinson Wright PLLC
  • -
  • USA
  • -
  • February 20 2015

Last month, Federal agencies issued frameworks for improving the U.S. health care system by increasingly tying value based payments to the delivery

Clinical trial and Medicare provider quality improvement provisions in House Committee 21st Century Cures discussion draft

  • Ropes & Gray LLP
  • -
  • USA
  • -
  • February 20 2015

On January 27, 2015, the House Energy & Commerce Committee ("Committee") released a discussion draft of comprehensive medical innovation reform

Employers with group health plans: have you notified state regulators of the breach?

  • McDermott Will & Emery
  • -
  • USA
  • -
  • February 20 2015

Data security breaches affecting large segments of the U.S. population continue to dominate the news. Over the past few years, there has been

S.D. Texas: hospital cannot be sued for increased risk of future harm from data breach

  • Hall Render Killian Heath & Lyman PC
  • -
  • USA
  • -
  • February 20 2015

This month's announcement of the recent Anthem Data Breach sent shockwaves through the health care industry with some experts referring to 2015 as

The audits are coming: OCR HIPAA compliance audits on the horizon

  • Bradley Arant Boult Cummings LLP
  • -
  • USA
  • -
  • February 19 2015

The Department of Health and Human Services Office for Civil Rights ("OCR") will soon begin auditing covered entities for compliance with the HIPAA

Navigating litigation and tort liability risks for mobile health and health IT applications

  • Arnold & Porter LLP
  • -
  • USA
  • -
  • February 18 2015

In the last ten years, mobile applications ("apps") have become an integral part of daily life for people throughout the world. Manufacturers have

Were you affected by the Anthem breach? Answers to these questions may help

  • Quarles & Brady LLP
  • -
  • USA
  • -
  • February 18 2015

It's being called "a very sophisticated external cyber-attack." With the theft of 80 million of its customers' and employees' records, Anthem Health

FDA extends risk-based medical app approach to Medical Device Data Systems in new guidance

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • February 17 2015

The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems

Preparing for Phase 2 HIPAA audits: it’s all about the documentation

  • Morgan Lewis & Bockius LLP
  • -
  • USA
  • -
  • February 17 2015

The launch of Phase 2 HIPAA audits is imminent. Although any individual hospital has only a small chance of getting audited, preparation helps