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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


HIPAA's unanswered questions
  • Wiley Rein LLP
  • USA
  • September 13 2012

Another month goes by without the publication of the final Health Insurance Portability and Accountability Health Information Technology for Economic and Clinical Health (HIPAAHITECH) rules


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


A new HIPAA era emerges
  • Wiley Rein LLP
  • USA
  • March 16 2009

After years of debate with little progress, a new Health Insurance Portability and Accountability Act (HIPAA) era has become a reality through the economic stimulus legislation


Summary of the new HIPAAHITECH omnibus regulation
  • Wiley Rein LLP
  • USA
  • January 28 2013

After almost four years, the Department of Health and Human Services (HHS) finally has released its "omnibus" Health Insurance Portability and


New California law forbids forced RFID implantation in humans
  • Wiley Rein LLP
  • USA
  • November 2 2007

California has enacted a statute prohibiting the compelled or coerced implantation of a subdermal identification device, such as a Radio Frequency Identification (RFID) microchip or a newer chipless "RFID tattoo."


Moving past the new HIPAA rules
  • Wiley Rein LLP
  • USA
  • September 3 2013

So, you're a HIPAA covered entity or business associate who is in the final throes of revamping (or creating) appropriate and compliant HIPAA Privacy


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


Case filed by Minnesota raises significant HIPAA enforcement issues
  • Wiley Rein LLP
  • USA
  • April 5 2012

A recent lawsuit brought by the Attorney General (AG) of Minnesota raises significant enforcement issues related to the Health Insurance Portability and Accountability Act (HIPAA


Is HIPAA enforcement finally getting tougher?
  • Wiley Rein LLP
  • USA
  • April 5 2012

With its most recent enforcement effort, the Department of Health and Human Services (HHS) may finally have signaled the beginning of a new enforcement era for Health Insurance Portability and Accountability Act (HIPAA) privacy and security violations