For how we live.
A final FDA guidance treats the on-screen output of software sent with a prescription drug as a type of drug labelling, and says how the prescribing information should describe it and when sponsors submit it for review.
A final FDA guidance sets out the safety information companies should provide when notifying the agency of a new dietary ingredient, replacing the old 'comprehensive safety profile' with a single 'safety narrative.'
A proposed rule would cut the Part D generic copay from $1 to $0 for the lowest-income dual eligibles in 2028, tighten Medicare Advantage directory accuracy, and add PBM transparency rules. Comments close 15 December.
The Fit-for-Purpose Rare Disease Framework Initiative launches with a 28 October public meeting and a request for comments. The FDA wants to tailor its review to very small patient populations.
A new 30-day order under the Public Health Service Act continues suspending the entry of certain travellers recently in DR Congo, Uganda or South Sudan. It runs through 10 November; comments close 30 October.
The government is gathering evidence to build step-count and muscle-strengthening guidance into the Physical Activity Guidelines for Americans, a supplement to the 2018 edition. Written comments close 12 November 2026.
A final rule amends 80 FDA standards of identity so makers can replace some or all added salt with substitutes, part of a push to cut sodium tied to high blood pressure. It takes effect 14 December 2026.
A final question-and-answer guidance tells biosimilar makers what data to file when they change how an approved product is made, fulfilling a 2022 user-fee commitment. It was issued on 13 October 2026.
A proposed rule would push several compliance dates under the 2024 trichloroethylene risk rule to 31 December 2027, giving processors and refrigerant makers more time to drop the solvent. Comments close 13 November.
A draft guidance published 9 October would spare mid-sized retail food establishments and restaurants from all Food Traceability Rule requirements. Comments close 23 November; a public meeting follows on 6 November.
Among privately insured patients, 63% with IVF coverage had a baby within 2.5 years versus 53% without. The gap was driven mostly by covered patients starting more cycles — not a higher success rate per cycle.
A CMS and CDC proposed rule would codify pandemic-era remote review of digital lab data, allow digital images in gynaecologic cytology proficiency testing, and ease 2024 staffing rules. Comments close 7 December.
A tri-agency final rule, effective 7 December, overhauls the machine-readable price files insurers must post and requires cost estimates by phone. The changes apply to plan years from 1 January 2027.
A draft NIH policy out for comment would require researchers to share plain-language summary results with clinical research participants for all NIH-supported studies, unless justifiably not appropriate.
HRSA has finalised eligibility guidelines for its Living Organ Donation Reimbursement Program under the HOLD Act, which bars considering the recipient's income. Eligibility now turns on the donor's own income.
A hybrid public meeting on 26 October will discuss proposed BsUFA IV recommendations. The fees that fund FDA review of biosimilar applications expire in September 2027 and need new legislation to continue.
The final FY2027 rule lifts the federal per diem base rate to $912.40 and the electroconvulsive-therapy rate to $688.59 from 1 October, adds a standardised patient-assessment tool, and drops two quality measures.
A mandatory CMS payment model finalised 2 October recalculates inflation rebates for certain physician-administered drugs against an international benchmark, and can cut a patient's coinsurance to 10%.
A new history of Norway's 1975 ban — one of the WHO's three 'best buys' against alcohol harm — traces how it survived courts, alcohol-free beer and social media, and why pressure to modernise it worries defenders.
A final action moves the Serious-area deadline for the Los Angeles-South Coast fine-particle area from December 2025 to December 2030, after California showed on-time attainment was impracticable. Effective 2 November.
A final order classifies the flushing and storage solution for vascular autografts as Class II with special controls, codifying a 2023 De Novo decision on Marizyme's DuraGraft and setting the bar for future copies.
A new draft guidance sets out the agency's current thinking on the non-clinical and clinical data it expects in premarket submissions for robotically-assisted surgical devices. Comments are due 24 November.
An interim final rule lets HHS freeze federal-marketplace registration for agents and brokers without a current plan-year agreement. CMS imposed the pause immediately; it runs until 1 February 2027.
A federal rule now requires certified electronic health records to publish a standard set of facts about each predictive algorithm they ship, including how it was validated and whether it was tested for fairness.
The Women's Preventive Services Initiative now endorses patient-collected HPV tests for average-risk women aged 30 to 65. HRSA has adopted the update for no-cost insurance coverage from 2027.
Under Article 6, AI that is or sits inside a device already needing an independent safety check counts as high-risk. A 70-study review finds the trouble is overlap with existing device law.
CMS took comment through 18 September 2026 on draft rules for how manufacturers must deliver negotiated drug prices in 2028. The mechanism is a refund owed within 14 days, not a lower shelf price.
The agency is repealing the carbon-capture-based standards at the heart of the 2024 rule, saying compliance-cost savings outweigh the emission cuts. It takes effect on 16 November 2026.
The RAPID pathway would issue a proposed national coverage decision the day a device clears the FDA, cutting a process that normally runs 9 to 12 months. The trade-off is evidence.
New guidelines set how the program, launched in July 2025, screens people aged 50 to 70 with a 30 pack-year smoking history using two-yearly low-dose CT scans.
Medicare paid over $500 million for remote monitoring in 2024, but a watchdog found 43% of patients didn't get the full service — and rigorous evidence that it improves outcomes remains limited.
Reviews find portals may improve awareness and the patient–doctor relationship, with unclear effect on efficiency. Under new US rules, patients now see 40% of results before their clinician does.
Analysing 64.8 million births from 2005 to 2022, researchers found policies such as physician-only requirements and 20-week bans tied to higher odds of preterm birth or low Apgar scores.
A section 564 declaration, prompted by a July determination from the Secretary of War, opens the door to authorising unapproved drugs for acute pain in combat and CBRN casualties.
The Vaccine Integrity Project, formed in 2025 amid disruptions to the CDC's immunisation advisory committee, sets out its process for reviewing 2026–2027 respiratory-season vaccines.
The patented method uses mifepristone for hypercortisolism-related insulin resistance, with dosing capped to avoid over-activating the stress-hormone axis. The public can object before the deal closes.
A prospective, quasi-experimental study links the air-quality gains after China's 2013 Clean Air Act to an average 6.6-percentage-point reduction in predicted cardiovascular risk.
The list price is the sticker; the net price is what the maker keeps after rebates. For one insulin, list rose 27% over five years as the net price fell 10%. Who you are decides which you pay.
Thirty-two interviews across Uruguay, Argentina, Chile and Mexico find implementation turned on governance, not software. A separate patent analysis shows where digital therapeutics are not being built.
A review by the country's Public Health Authority credits enforcement and awareness campaigns for falls in crashes, deaths and injuries from 2013 to 2023 — while naming what still holds the Vision 2030 target back.
A study of Current Population Survey data finds 19.8% of likely expansion enrollees sit near the 20-hour threshold or report variable hours. Women are at higher risk than men.
Americans owed about $140 billion in medical bills in collections. But two randomized experiments that relieved debt found no average effect on credit, financial distress or mental health.
Across 26 states, expansion raised the Medicaid-paid share of deliveries by 5.2% and changed the severe maternal morbidity rate by 0.02% — an interval that includes zero in both directions.
Peer-reviewed work in 2026 argues the effects reach past medicine shortages into financing, procurement, workforce and continuity of care — and frames the finding as association, not proof of cause.
The committee that decides what Israel's national insurance covers added new cancer and depression drugs to the 2026 list — and turned down an early Alzheimer's treatment because of what it would have cost.
Pharmacy benefit managers sit between you, your insurer and the pharmacy. The three largest process nearly 80% of US prescriptions, and a federal regulator says the structure can raise costs.
The pandemic-era rules letting Medicare patients see a doctor from home, anywhere in the country, are now locked in through the end of 2027 — the longest extension since they were created.
Twenty-five states wanted the rule paused while they sued. The judge said the 90% federal reimbursement for setup costs undercut their case for emergency relief — not that their underlying legal argument was wrong.
Coverage access rose from 86% to 96.4% of the population in four years. The government's own target — 80 years by 2030 — is now less than a year of progress away.
Since 2021, hospitals must post the rates they negotiate with each insurer. The data confirms the same procedure at the same hospital varies widely by which insurer is paying.
Physician surveys report delays and abandoned treatment; those are self-reported. A harder number: a federal audit found 13% of Medicare Advantage denials met Medicare's own coverage rules.
Medicare's cap is statutory; the commercial version is a voluntary manufacturer promise with conditions. Before the caps, 1.3 million adults rationed insulin because of cost.
Most wellness apps make no disease claim and face no federal review. Into that gap, US states are writing their own AI-in-mental-health laws — four already diverge, leaving users unevenly protected.
The prices apply only to 10 drugs, only in Medicare, and only from January 2026. Here is exactly which drugs, by how much, and who actually sees the difference.
The final rule raises operating payment rates 2.4% and directs about $2.9 billion more to acute-care hospitals in the year from 1 October 2026. Hospital groups called the increase too low.
The FDA's approval bar requires no clinically meaningful difference from the original, and a large switching trial found no loss of control. The savings gap is a market problem, not a safety one.
Across all drugs, US prices are 2.78 times those in 33 other wealthy countries. The gap is not that Americans use more medicine — it is that no one sets the launch price.
A quasi-experimental analysis of 23 hospitals finds about 95 additional self-harm and suicide-related emergency visits a month after the law changed, alongside fewer psychiatric admissions.
Developing countries paid a record US$1.4 trillion in debt service in 2023. A 105-country study finds debt servicing nudges the health-financing mix toward out-of-pocket, but only modestly.
One agency asked how to measure AI devices after they are deployed. Another asked how to speed adoption up. The offices that would answer the first question are losing staff.
The WISeR model starts on 1 January in six states. The contractors running it are paid out of the savings their determinations produce — the design feature doctors keep pointing at.
The 2024 amendments to the International Health Regulations took effect in September 2025, adding a 'pandemic emergency' tier. The United States formally rejected them.
IHME's annual accounting puts development assistance for health at less than half its 2021 peak, with no recovery forecast to 2030. A companion model estimates what that means for tuberculosis.
The World Health Assembly approved US$6.2 billion for 2026-2027 after trimming the base to US$4.27 billion. The notified US withdrawal cut the assessments available for it by US$311.1 million.
For the first time, Part D limits annual out-of-pocket drug spending to $2,000, with an option to pay it in monthly installments. Over a million heart patients alone were spending more.
Reported health-data breaches rose 100% from 2018 to 2023 and the people affected by them 950%. A federal proposal would drop the rule's 'addressable' loophole and require encryption, multi-factor login and more.