Jennifer S. Geetter

Jennifer S. Geetter

McDermott Will & Emery

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Final Rule Modernizes Substance Use Disorder Patient Record Confidentiality Regulations

On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its long-awaited final rule amending the confidentiality regulations at 42 CFR Part 2 (Part 2) that apply to federally...more

2/8/2017 - Confidentiality Policies Health Care Providers Medicare Mental Health Patient Privacy Rights SAMHSA SNPRM Substance Abuse

HHS Finalizes Toned-Down Version of Common Rule Overhaul

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

2/7/2017 - Clinical Trials HHS Human Rights Informed Consent IRB Medical Devices Medical Research NPRM Proposed Regulation Scientific Research The Common Rule

HHS Finalizes Overhaul of Federal Human Subjects Research Protections

In Depth - On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.”...more

1/19/2017 - Final Rules HHS Research and Development The Common Rule

OMB Reviewing Common Rule Overhaul

On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often...more

1/6/2017 - Advanced Notice of Proposed Rulemaking (ANPRM) HHS Office for Human Research Protections (OHRP) OMB The Common Rule

21st Century Cures: Modernizing Public and Private Research

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

12/19/2016 - 21st Century Cures Initiative Biotechnology FDA Life Sciences NIH Research and Development

21st Century Cures: Tackling the Growing Problem of Mental Health and Substance Use Disorders

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

12/14/2016 - 21st Century Cures Initiative Health Care Providers HHS HIPAA Medicaid Mental Health Opioid Substance Abuse

21st Century Cures: Required Exploration of Telehealth Solutions

President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide...more

12/14/2016 - 21st Century Cures Initiative CMS Health Care Providers Healthcare Medicare MedPAC Telehealth

21st Century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

12/13/2016 - 21st Century Cures Initiative Barack Obama Digital Health EHR Health Information Technologies HHS Research and Development

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more

4/21/2016 - Breach Notification Rule FDCA FTC HIPAA Mobile Health Apps

SAMHSA Proposes Changes to Substance Use Disorder Treatment Confidentiality Regulations

On February 5, 2015, the Substance Abuse and Mental Health Administration (SAMHSA) released a long-awaited proposed rule to modify the confidentiality rules that apply to patient identifying information generated by federally...more

3/10/2016 - Confidential Documents Drug & Alcohol Abuse EHR HIPAA Medical Records OCR SAMHSA

Significant Telehealth Expansion Proposed in Bipartisan Senate Bill

Earlier this month, a bipartisan group, led by U.S. Senator Brian Schatz (D-Hawaii), introduced a bill in the Senate focused on promoting cost savings and quality care under the Medicare program through the use of telehealth...more

2/29/2016 - Bipartisan Agreement HHS Hospitals Medicare Medicare Advantage Native American Issues Physician Medicare Reimbursements Telehealth

FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel...more

2/18/2016 - Big Data Biologics Center for Drug Evaluation and Research (CDER) Databases Electronic Medical Records FDA Medical Devices Prescription Drugs

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

1/28/2016 - Cybersecurity Draft Guidance FDA Health Care Providers Health Information Technologies Medical Devices Patient Safety Risk Management

New HIPAA Privacy Rule Permits Disclosures to Background Check System

On January 6, 2016, the U.S. Department of Health and Human Services (HHS) issued a final rule amending the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to strengthen the current background check...more

1/14/2016 - Disclosure Firearms HHS HIPAA Mental Health NICS PHI Popular

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

9/9/2015 - Clinical Trials Comment Period Data Security Exemptions HHS HIPAA Human Genome Project Informed Consent IRB Jurisdiction Medical Research NPRM Proposed Regulation Recordkeeping Requirements Scientific Research The Common Rule

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 Industry 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 Industry 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

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