Daniel F. Gottlieb

Daniel F. Gottlieb

McDermott Will & Emery

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OCR Launches Phase 2 HIPAA Audit Program with Pre-Audit Screening Surveys

Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entities have reported that the U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently sent pre-audit screening surveys...more

5/18/2015 - Audits Breach Notification Rule Business Associates Covered Entities De-Identified Protected Health Information Electronic Medical Records Health Care Providers HIPAA Medical Records OCR PHI

OCR Transmits Pre-Audit Screening Surveys to Covered Entities for Phase 2 HIPAA Compliance Audits

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently transmitted HIPAA pre-audit screening surveys to covered entities that may be selected for a second phase of HIPAA compliance audits...more

5/8/2015 - Business Associates Covered Entities Electronic Medical Records HIPAA HITECH OCR PHI

FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the...more

2/5/2015 - Draft Guidance FDA Medical Device Accessories Medical Devices

Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission...more

12/11/2014 - Africa Anti-Spam Legislation Canada China Cybersecurity Data Protection EU EU Data Protection Laws FTC Latin America Legislative Agendas

OCR to Begin Phase 2 of HIPAA Audit Program

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) will soon begin a second phase of audits (Phase 2 Audits) of compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA)...more

7/30/2014 - Audits Best Management Practices Business Associates Chief Compliance Officers Covered Entities Cybersecurity Data Breach Enforcement Healthcare Providers HHS HIPAA HITECH Hospitals PHI Popular

The New Normal: Big Data Comes of Age

On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing...more

5/13/2014 - Barack Obama Big Data Data Breach Data Protection ECPA Healthcare Legislative Agendas Life Sciences Privacy Laws Privacy Policy Public Policy

ACA Proposed Rule to Require Health Insurers to Certify Compliance with HIPAA Electronic Transaction Requirements

The U.S. Department of Health and Human Services issued a proposed rule to implement the ACA requirement that health insurers and other HIPAA-covered health plans certify compliance with the standards and operating rules for...more

1/9/2014 - Affordable Care Act EFTs Healthcare Healthcare Reform HHS HIPAA Qualified Health Plans

HIPAA Omnibus Final Rule Compliance Date Is Only Two Months Away

The compliance date for the omnibus final rule amending the privacy, security, breach notification and enforcement regulations under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information...more

7/25/2013 - Breach Notification Rule Compliance Data Breach Data Protection Deadlines Enforcement Final Rules Healthcare HIPAA HIPAA Omnibus Rule Privacy Policy

What Have We Learned from Audits under the Medicare EHR Incentive Program?

Through the first half of this year, the Centers for Medicare & Medicaid Services auditor has conducted numerous pre- and post-payment audits of meaningful use attestations submitted by eligible providers to the Medicare...more

7/11/2013 - Audits CMS EHR Electronic Medical Records Eligibility Medicaid Medicare

HHS Extends Sunset Date for Stark Exception and Anti-Kickback Safe Harbor for EHR Donations

The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services issued proposed rules that would extend the sunset date for the Stark Law exception and the federal Anti-Kickback Statute safe...more

4/19/2013 - Anti-Kickback Statute CMS EHR HHS Medicaid Medicare OIG Safe Harbors Stark Law Sunset Provisions

FTC Recommends Privacy Practices for Mobile Apps

A new Federal Trade Commission report urges mobile app platforms and developers to better inform consumers about their privacy practices. Mobile app platforms and developers should review their privacy policies to ensure...more

2/26/2013 - Advertising Networks App Developers COPPA Dashboard Do Not Track FTC Geolocation Information Sharing Just-In-Time Disclosures Mobile App Privacy Guidelines Mobile Apps Mobile Privacy Disclosures Privacy Policy Third-Party Trade Associations

OCR Issues Final Modifications to the HIPAA Privacy, Security, Breach Notification and Enforcement Rules to Implement the HITECH...

On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security...more

2/21/2013 - Business Associates Covered Entities Data Breach Data Protection Enforcement GINA HHS HIPAA HITECH Notice Requirements OCR PHI Privacy Rule

HIPAA De-Identification Guidance

Office of Civil Rights has released additional guidance addressing the de-identification of protected health information in accordance with the HIPAA Privacy Rule. Covered entities should review their current...more

12/12/2012 - Compliance De-Identification Healthcare Healthcare Professionals HIPAA HITECH OCR PHI

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