News & Analysis as of

Health Insurance Portability and Accountability Act (HIPAA) The Common Rule

Davis Wright Tremaine LLP

Is AI Development "Research" Under HIPAA?

Continued advancement in artificial intelligence offers great promise to improve health care. But AI feeds on tremendous amounts of data, and using protected health information (PHI) to develop or improve AI often involves...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

K&L Gates LLP

Health Care Triage: When Regulatory Review is Necessary: Clinical Research vs. Quality Initiatives

K&L Gates LLP on

In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining...more

Bradley Arant Boult Cummings LLP

Governor Approves CCPA Amendment to Further Except Healthcare and Research Information

Gov. Gavin Newsom recently approved A.B. 713, a bill that creates further CCPA exceptions for healthcare and research information. The bill is especially potent in the COVID-19 era where the need for medical research is...more

McDermott Will & Emery

European Data Protection Supervisor Issues Opinion on Conducting Research Involving European Personal Data

McDermott Will & Emery on

The European Data Protection Supervisor, the independent European Union authority responsible for data protection regulatory oversight, issued a preliminary opinion on data protection and scientific research. The Opinion...more

McDermott Will & Emery

California Bill Proposes CCPA Exceptions for HIPAA De-identified Information, Other Health Data

McDermott Will & Emery on

On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...more

Verrill

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

Verrill on

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more

Epstein Becker & Green

Six Key Changes to the Common Rule

Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

BakerHostetler

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

BakerHostetler on

The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

McDermott Will & Emery

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

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