Deep Dive

Multiple U.S. states relax 'certificate of need' regulations to expand medical bed supply

Multiple U.S. states are gradually eliminating or relaxing 'certificate of need' (CON) regulations to address growing medical demand and bed shortages. Research shows that CON laws have limited effectiveness in controlling costs, improving quality, and enhancing service accessibility, and may even produce counterproductive effects. The experience of temporary waivers during the pandemic, along with pressure from rising long-term healthcare expenditures, is prompting states to explore new regulatory mechanisms.

AI is expected to become a transformative force, but applications in the medical field require 'extreme caution'

At the HLTH conference, experts said AI can alleviate medical staffing shortages, but progress must be made cautiously. Administrative automation tools carry lower risks, while clinical AI requires rigorous testing.

FDA's New Rule on Laboratory-Developed Tests Takes Effect: A Five-Step Guide to Laboratory Compliance

In May, the U.S. FDA issued a final rule bringing laboratory-developed tests (LDTs) under medical device regulation. This article outlines five key steps for laboratories to address the new rule, covering adverse event reporting, registration, quality systems, and exemption scenarios.

Tech Giants Deploy Medical AI Platforms, Clarifying Responsible Implementation Paths

At the HLTH conference, executives from major U.S. tech companies pledged to lead the next wave of innovation in medical AI, shifting from point tools to platform-based solutions. Companies such as Google and Microsoft emphasized co-developing AI applications with healthcare systems, but diverged on testing responsibilities, clinical oversight, and resource gaps for smaller institutions.

AI medical devices surge tenfold in a decade: FDA has authorized 950 products

Data from the U.S. Food and Drug Administration (FDA) database shows that as of August 7, 2024, 950 artificial intelligence (AI) or machine learning (ML) medical devices have been authorized. Since the first AI device was approved in 1995, submissions have surged in recent years: 6 were authorized in 2015, increasing to 221 in 2023. Experts point to device connectivity, increased investment, and greater regulatory familiarity as key drivers. Imaging accounts for more than three-quarters of authorized devices, but specialties such as cardiology are rapidly expanding. GE HealthCare and Siemens Healthineers hold the most AI devices, with 81 and 70, respectively. Most products are cleared via the 510(k) pathway, with approximately 97% being 510(k) clearances.

Four steps to reduce cybersecurity threats from legacy medical devices

The U.S. FDA implemented new regulations last year to strengthen cybersecurity oversight of medical devices, but legacy devices remain a challenge. Experts recommend that hospitals reduce risks through four steps: identifying devices, understanding vulnerabilities, network segmentation, and shutting down devices when necessary.

Q2 Earnings Season: Medicaid Replaces Medicare Advantage as Primary Concern for Health Insurers

In the second quarter of 2024, the Medicaid businesses of major U.S. health insurers became a new financial pressure point, replacing the previously closely watched Medicare Advantage plans. After states resumed eligibility reviews, changes in Medicaid membership composition drove up insurer costs, causing several companies to lower their full-year earnings guidance. Meanwhile, utilization rates for MA plans remained persistently high, with companies such as CVS and Humana suffering significant impacts.

FDA Laboratory-Developed Test Rule May Become First Test of Agency Power After Chevron Doctrine Overturned

The U.S. Supreme Court voted 6-3 in late June to overturn the Chevron doctrine, meaning courts are no longer required to defer to federal agencies' interpretations of ambiguous congressional statutes. This ruling could affect the FDA's regulatory rule for laboratory-developed tests (LDTs), which has already sparked industry litigation. Lawyers note that the LDT lawsuit will serve as a 'barometer' for observing changes in FDA power after the Chevron doctrine was overturned.

Humana and CVS are downsizing their Medicare Advantage plans for 2025. Which insurers could benefit?

2024 Q1 Insurance Industry Watch: Medicare Advantage Turmoil and Change Healthcare Incident Have Divergent Impacts

In the first quarter of 2024, the U.S. health insurance industry opened under the dual impact of Medicare Advantage market turmoil and the Change Healthcare cyberattack. Although the cyberattack severely affected healthcare providers, payers generally reported limited financial impact. Meanwhile, rising medical costs in Medicare Advantage led to profit declines for some insurers, while new CMS regulations brought D-SNP growth opportunities for Medicaid insurers.