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FDA Isn't Moving to Regulate Devices that Track Fitness Regimes!

At long last, the Food and Drug Administration issued its Nonbinding Recommendations and Guidance regarding "General Wellness: Policy for Low Risk Devices," announcing it will not regulate "low-risk general wellness...more

Phase 2 of the OCR HIPAA Audit Program Already Underway

On March 21, 2016, the Department of Health and Human Services, Office for Civil Rights (OCR) announced the launch of the long-awaited Phase 2 HIPAA Audit Program (Phase 2), and OCR activities related to Phase 2 are already...more

Don't Fumble Your HIPAA Obligations: Ensure Your HIPAA Playbook Implements Appropriate Protections for Patients

The injuries suffered by a professional football player brought the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations ("HIPAA") onto center stage of the media during the days...more

Telesurgery: A New Frontier or Just Risky Business?

Security experts at the University of Washington in Seattle recently set out to expose potential privacy and security vulnerabilities that exist in telesurgery. As first reported by MIT Technology Review, experts hacked a...more

It’s No Surprise: Health Care Data Breaches Are on the Rise and So Is Government Enforcement

In This Issue: - The Take-Aways for Covered Entities and Business Associates - For More Information - Excerpt from The Take-Aways for Covered Entities and Business Associates: As a majority of the...more

HHS Extends Patient Access To Laboratories

On February 6, 2014, the Department of Health and Human Services (HHS) published a Final Rule amending regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance...more

2/24/2014  /  CLIA , EHR , HHS , HIPAA , OCR , PHI
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