Medical Regulation

My Body, Whose Choice?

My Body, Whose Choice?

States should require doctors to seek informed consent before performing pelvic exams on anesthetized women.

Proposed Rule Seeks to Promote Value-Based Health Care

Proposed Rule Seeks to Promote Value-Based Health Care

Federal regulators seek to expand safe harbors for provider care coordination arrangements.

How FDA Drug Review Contributed to the Opioid Epidemic

How FDA Drug Review Contributed to the Opioid Epidemic

Scholars argue that FDA should use larger health data sets in its approval process for high-risk drugs.

Proposed Rule Aims to Make Drug Pricing More Transparent

Proposed Rule Aims to Make Drug Pricing More Transparent

A proposed requirement to display drug list prices in advertisements draws controversy.

Regulatory Collaboration Is Key to Public Health Success

Regulatory Collaboration Is Key to Public Health Success

Federal health agencies should work together to address public health problems.

Invoking a Right to Try in Regenerative Medicine

Invoking a Right to Try in Regenerative Medicine

Scholars caution against using the Right to Try Act to skirt regulation for regenerative therapies.

FDA Reform Needs to Look More Like Tax Reform

FDA Reform Needs to Look More Like Tax Reform

U.S. regulators should model the medical device classification process on recent tax reform.

How Regulation Can Improve Surgery

How Regulation Can Improve Surgery

Scholar argues that agencies should collect evidence on surgical procedures to help implement best practices.

Gene Editing of Human Embryos Prompts Calls For Regulation

Gene Editing of Human Embryos Prompts Calls For Regulation

Despite ethical concerns, scholar argues that gene editing of human embryos should not be banned.

Improving Federal Regulation of Medical Algorithms

Improving Federal Regulation of Medical Algorithms

Scholar argues that FDA should reform its regulation of algorithm-based medicine.

Addressing the International Legal Challenges of Genetic Engineering

Addressing the International Legal Challenges of Genetic Engineering

In keynote address, Gary Marchant discusses the transnational implications of genetic engineering.

How Much of an Income Drop Will Take a Life?

How Much of an Income Drop Will Take a Life?

Policymakers should consider the impact of their decisions on not just wealth, but also human life.