M. Leeann Habte

M. Leeann Habte

Foley & Lardner LLP

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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

5/13/2016 - FDA Manufacturers Medical Device Data System Medical Devices Patient Safety Unique Device Identifiers

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

4/26/2016 - Breach Notification Rule Business Associates Covered Entities HIPAA Audits OCR PHI Risk Assessment

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

4/19/2016 - App Developers Breach Notification Rule Data Security FDA FDCA FTC FTCA HIPAA Mobile Health Apps New Guidance OCR ONC

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

3/28/2016 - Business Associates Corrective Actions Covered Entities Cybersecurity Framework HIPAA Audits NIST OCR ONC Policies and Procedures Risk Assessment Training Requirements

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

3/3/2016 - Attestation Deadlines CMS Critical Access Hospitals Electronic Health Record Incentives Health Care Providers Hospitals Meaningful Use Medicare Patient Access and Medicare Protection Act

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

2/11/2016 - Alternative Payment Models (APM) Comment Period Drug & Alcohol Abuse Health Information Technologies Patient Privacy Rights Proposed Regulation SAMHSA Written Consent

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

5/21/2015 - EHR Health Care Providers HIPAA HITECH ONC Security and Privacy Controls

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

4/3/2015 - CMS EHR Health Care Providers Hospitals Meaningful Use Medicaid Medicare Physicians Proposed Regulation

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

3/2/2015 - Big Data Healthcare PHI Popular Regulatory Standards

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

12/19/2014 - Audits CMS Electronic Health Record Incentives Healthcare Facilities Hospitals Meaningful Use Physicians

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

10/2/2014 - Genetic Materials Healthcare Medical Research Personalized Medicine Privacy Laws Technology

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

6/10/2014 - Affordable Care Act Civil Monetary Penalty Financial Conduct Authority (FCA) HHS Hospitals Medicare OIG Overpayment Proposed Regulation

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

1/24/2013 - Business Associates Data Breach Data Protection Disclosure Requirements Enforcement Fundraisers GINA HHS HIPAA HIPAA Omnibus Rule HITECH Marketing OCR PHI Privacy Policy

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

1/8/2013 - Compliance Data Breach Data Protection Health Information Technologies HHS HIPAA HONI Mobile Devices OCR Patient Confidentiality Breaches Settlement

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

12/4/2012 - De-Identification Health Care Providers Healthcare HHS HIPAA HITECH OCR PHI Safe Harbors

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