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Results: 1-10 of 48

FDA clarifies which mhealth apps require pre-market notification as medical devices
  • Wiley Rein LLP
  • USA
  • September 30 2013

On September 25, 2013, the U.S. Food and Drug Administration (FDA) issued its much-anticipated Final Guidance for Industry on Mobile Medical


FDASIA report proposes rules of the road for Health IT
  • Wiley Rein LLP
  • USA
  • April 7 2014

The long awaited FDASIA Health IT Report proposes a strategy for calibrating regulatory oversight to risk and clarifying the regulatory obligations


FTC agreement adds to the accretive health enforcement saga
  • Wiley Rein LLP
  • USA
  • January 17 2014

On New Year's Eve, the Federal Trade Commission (FTC) announced a consent order settlement with Accretive Health, Inc., purporting to address the


HIPAAHITECH compliance is finally here
  • Wiley Rein LLP
  • USA
  • September 17 2013

More than four and a half years since the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, the time for


Health care, employers, confusion, and controversy
  • Wiley Rein LLP
  • USA
  • March 14 2014

The recent controversy about AOL CEO Tim Armstrong's comments on employee health care expenses reflects ongoing confusion about the rules for


Unfinished business: solving the HIPAA accounting rule dilemma
  • Wiley Rein LLP
  • USA
  • May 9 2013

Now that the Health Information Technology for Economic and Clinical Health (HITECH) rules finally have been released, health care companies and


Georgia Supreme Court uses HIPAA preemption to nullify medical malpractice reform
  • Wiley Rein LLP
  • USA
  • July 2 2007

The Georgia Supreme Court's potentially important May 14 decision in Allen v. Wright, 2007 Ga. Lexis 343, held that the HIPAA Privacy Rule preempted Georgia's 2005 tort reform statute requiring malpractice plaintiffs to file with their complaints a "medical authorization form" enabling the defendants' attorneys to obtain and disclose protected health information to facilitate their defense of the plaintiff's claims


Health care privacy in 2007
  • Wiley Rein LLP
  • USA
  • January 29 2007

The focus of health care privacy in 2007 will be on new enforcement issues, new opportunities and challenges related to the use of health care information


The health care privacy debate heats up
  • Wiley Rein LLP
  • USA
  • September 5 2007

While Congress and many others continue to discuss whether the current enforcement approach to health care privacy is appropriate, a broader debate is emerging about the suitability of the existing privacy rules in today's evolving health care information environment


Are troublesome HIPAA changes on the way?
  • Wiley Rein LLP
  • USA
  • June 6 2008

Recent progress toward developing electronic medical records and personal health records has generated an enormous amount of debate about whether new privacy and security rules are necessary for this new electronic environment