Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

Kaiser Permanente agrees to $46M settlement over data incident affecting 13.4M people
The managed care company does not admit to doing anything wrong. The data breach constituted its use of third-party tracking technology on its website, which shared data with Google, Microsoft, Twitter, Meta and others.
Plan to extend ACA tax credits finds bipartisan support in the House
The new proposal to extend expanded subsidies for health plans sold through the Affordable Care Act is being backed by 35 Republicans and Democrats—but as the New York Times points out, it will be hard for the bill to get a floor vote.
FDA clears new left-heart access system from Atraverse Medical
The Hotwire Transseptal Access System includes the Hotwire RF Generator and Hotwire RF Guidewire, giving electrophysiologists the tools they need for left-heart access.
$V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.$
FDA panel votes against approving first-of-its-kind heart failure device
All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell.
Drug discounts for safety-net hospitals up in the air and into the courts
HHS’s 340B drug discount program is set to shift to a rebate model on New Year’s Day. But a lawsuit and temporary restraining order filed by the AHA and others may block the change from going live on time.

Kaiser Permanente agrees to $46M settlement over data incident affecting 13.4M people

The managed care company does not admit to doing anything wrong. The data breach constituted its use of third-party tracking technology on its website, which shared data with Google, Microsoft, Twitter, Meta and others.

Plan to extend ACA tax credits finds bipartisan support in the House

The new proposal to extend expanded subsidies for health plans sold through the Affordable Care Act is being backed by 35 Republicans and Democrats—but as the New York Times points out, it will be hard for the bill to get a floor vote.

Hotwire Transseptal Access System Atraverse Medical

FDA clears new left-heart access system from Atraverse Medical

The Hotwire Transseptal Access System includes the Hotwire RF Generator and Hotwire RF Guidewire, giving electrophysiologists the tools they need for left-heart access.

$V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.$

FDA panel votes against approving first-of-its-kind heart failure device

All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell.

Drug discounts for safety-net hospitals up in the air and into the courts

HHS’s 340B drug discount program is set to shift to a rebate model on New Year’s Day. But a lawsuit and temporary restraining order filed by the AHA and others may block the change from going live on time.

FDA issues warning about Olympus ligating devices after 113 injuries

The nylon loop on some devices can fail to release while removing polyps. Because of the severe risk to patient health, the FDA has designated this recall a Class I.

FDA recall medical device recall product recall

FDA announces Class I recall of patches used for heart surgery

There is a risk of certain pericardial patches not being as strong or durable as needed. Customers are urged to identify, quarantine and replace these devices.

AI news & views in brief: State regulation ban or none, AI in healthcare advertising, more

Will there or won’t there be a federal moratorium on state-level regulation of AI? That’s only one question healthcare stakeholders are asking as 2025’s time begins running out.