Jennifer S. Geetter

Jennifer S. Geetter

McDermott Will & Emery

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White House Releases Draft Privacy Principles for the Precision Medicine Initiative

Six months after the Precision Medicine Initiative’s (Initiative’s) debut, the White House has released a working draft of proposed privacy and trust principles (the Principles) to govern future design and development efforts...more

7/31/2015 - Consent Data Privacy Data-Sharing Medical Research Obama Administration Patient Privacy Rights

Start with Security

On June 30, 2015, the Federal Trade Commission (FTC) published “Start with Security: A Guide for Businesses” (the Guide). The Guide is based on 10 “lessons learned” from the FTC’s more than 50 data-security...more

7/9/2015 - Best Practices Data Protection FTC Guide Security and Privacy Controls

CMS Releases Broad Data on Prescribing Patterns of Physicians and Providers Under Medicare Part D

In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more

5/26/2015 - CMS Data-Sharing Healthcare Medicare Medicare Part D Pharmaceutical Manufacturers Physicians Prescription Drugs

National Roadmap for Health Data Sharing: FTC Advocates Preservation of Privacy and Competition

On April 1, 2015, the Office of the National Coordinator for Health Information Technology (ONC), which assists with the coordination of federal policy on data sharing objectives and standards, issued its Shared Nationwide...more

4/17/2015 - Data-Sharing FTC Health Care Providers HIPAA ONC PHI

The Newborn Screening Saves Lives Reauthorization Act: Implications for Human Subjects Research

On March 16, 2015, the Newborn Screening Saves Lives Reauthorization Act of 2014 went into effect. The Act reauthorizes funding to improve and expand state-based programs that screen newborns for treatable, serious genetic...more

4/8/2015 - Funding Healthcare New Legislation

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

3/26/2015 - Clinical Trials FDA HHS Informed Consent Medical Research Pharmaceutical Scientific Research

A Closer Look at the White House’s Precision Medicine Initiative

On January 20, 2015, as part of his State of the Union address, President Obama announced the upcoming launch of the White House’s Precision Medicine Initiative (Initiative). The Initiative seeks to allocate $215 million in...more

3/5/2015

The Consumer Privacy Bill of Rights Redux

On February 27, 2015, the Obama White House released an “Administration Discussion Draft” of its Consumer Privacy Bill of Rights Act of 2015 (Proposed Consumer Privacy Act). ...more

3/4/2015 - Consumer Privacy Bill of Rights COPPA Cybersecurity FTC HIPAA Obama Administration Proposed Legislation

Consumer Health Information Update from Both Sides of the Atlantic

As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) —...more

3/2/2015 - Article 29 Working Group FTC Healthcare HIPAA Mobile Apps Patient Privacy Rights

The White House Calls for Action Where Congress Has Failed to Deliver - An In-Depth Analysis of President Obama’s January 2015...

In This Issue: - The President’s Plan for Securing Cyberspace - The President’s Plan for Safeguarding American Consumers and Families - Conclusion - Excerpt from The President’s Plan for Securing...more

2/13/2015 - Breach Notification Rule Cybersecurity Data Breach Data Protection Obama Administration Personal Data Notification and Protection Act

In with the New: 2014 Privacy, Advertising and Digital Media Predictions – Part I

What privacy, advertising and digital media trends will make headlines in 2015? Digital Health for one, Big Data for another....more

1/8/2015 - Advertising Big Data Digital Media FTC Healthcare Mobile Apps Mobile Devices Privacy Policy Wearable Technology

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

CMS Finalizes Proposal to Remove Continuing Medical Education Exclusion from Sunshine Act Regulations

On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final Rule), which also includes certain changes to the Sunshine Regulations. ...more

11/13/2014 - CMS Continuing Medical Education Final Rules Medicare Pharmaceutical Pharmaceutical Manufacturers Physician Fee Schedule Physicians Sunshine Act

CMS Proposes Removing CME Exclusion from Sunshine Act Regulations, Citing Redundancy with Indirect Payment Exclusion

In the July 3, 2014, issue of the Federal Register, The Centers for Medicare & Medicaid Services (CMS) published the proposed calendar year 2015 Medicare physician fee schedule update (the Proposed Rule). The Proposed Rule...more

8/8/2014 - Affordable Care Act CMS Continuing Medical Education Medicare Physician Medicare Reimbursements Proposed Regulation Sunshine Act

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

Thinking Outside the HIPAA Box

On Wednesday, May 7, the Federal Trade Commission (FTC) held the third of its Spring Seminars on emerging consumer privacy issues. This session focused on consumer-generated health information (CHI). CHI is data generated...more

5/12/2014 - Covered Entities FTC Internet Internet Privacy Mobile Apps Patient Privacy Rights PHI Privacy Concerns Privacy Policy

CMS Proposes to Expand Access to Part D Data for Research

On January 10, 2014, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to alter key components of the Medicare Advantage (MA) and Part D Programs (Proposed Rule). Understandably, the Proposed Rule...more

3/18/2014 - CMS Medicare Medicare Part D

Florida Medical Record Disclosure Law Preempted by HIPAA

The U.S. Court of Appeals for the 11th Circuit recently ruled that a Florida law requiring nursing homes to disclose patient records of deceased patients was preempted by the Health Insurance Portability and Accountability...more

5/20/2013 - Disclosure Requirements HIPAA Medical Records Nursing Homes Preemption

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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