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FDA Outlines Future Medical Device Coordinating Center

The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to...more

OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA)...more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Phase 2 of HIPAA Compliance Audits Now Underway

The Office of Civil Rights (OCR) within the U.S. Department of Health and Human Services (DHHS) recently announced that it has initiated Phase 2 of its audit program to assess Covered Entities’ and Business Associate’s...more

Recent EHR Meaningful Use Program Updates

As we enter the sixth year of the Medicare and Medicaid Electronic Health Records Incentive Programs (commonly referred to as the “Meaningful Use Programs”), the Centers for Medicare & Medicaid Services (CMS) continues to...more

SAMHSA Proposes Major Changes to Federal Substance Abuse Privacy Rule

On February 9, 2016, almost thirty years after the last substantive change to the federal regulations governing the confidentiality of alcohol and drug abuse patient records, the Substance Abuse and Mental Health Services...more

ONC Releases Updated Guide to Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic...more

CMS Releases Stage 3 Meaningful Use Proposed Rule

The Centers for Medicare & Medicaid Services (“CMS”) released the Stage 3 proposed rule to the Medicare and Medicaid Electronic Health Records Incentive Programs (“Proposed Rule”) on March 20, 2015. To provide context,...more

Tapping Into the Big Value of Health Care Big Data

In This Issue: - Executive Summary - Improving Care by Tapping Into the Data Goldmine - Big Opportunities Available in Big Data - Government Programs Supporting the Use of Big Data -...more

How to Prepare Your Hospital or Medical Practice for a Meaningful Use Audit

For the past several years, the Centers for Medicare and Medicaid Services (“CMS”) has incentivized hospitals and eligible professionals to adopt and make “meaningful use” of certified electronic health records (“EHR”)...more

Privacy Issues in the Sharing of Genetic Information

Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

OIG's Proposed Rule to Expand Civil Monetary Penalties

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) on May 12, 2014 published a proposed rule (Proposed Rule) that would implement the OIG’s expanded authority under the Affordable Care...more

HHS Issues Final Omnibus HIPAA/HITECH Rule

On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued the long-awaited omnibus final rule (the Rule) implementing changes in current regulations under the Health...more

First-Ever HIPAA Settlement Involving Fewer Than 500 Patients Announced

On January 2, 2013, the U.S. Department of Health and Human Services (HHS) announced a settlement with the Hospice of North Idaho (HONI) for potential HIPAA violations....more

Office of Civil Rights Releases Guidance on De-Identification of PHI Under HIPAA Privacy Rule

On November 26, 2012, the Department of Health and Human Services Office for Civil Rights (OCR) released long-overdue guidance on how covered entities subject to the Health Insurance Portability and Accountability Act (HIPAA)...more

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