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Delayed Reporting or Late FDA Warning on Breast Implant Cancer, Patient Advocates Say
The U.S. FDA recently issued a safety alert regarding squamous cell carcinoma associated with breast implants, but patient advocacy groups point out that the regulatory warning could have been issued earlier due to poor execution of post-market studies. This article outlines the event timeline, case data, and various perspectives.
Why Regulators Did Not Object to Amazon's One Medical Deal: Considerations Behind Data Concerns
Amazon's $3.9 billion acquisition of One Medical has been completed without regulatory obstruction. Consumer protection groups have expressed concerns, suggesting Amazon could misuse patient data and leverage its retail market advantages. Antitrust experts note that regulators found insufficient grounds to block the deal, but the FTC may still take action later.
Medicaid Eligibility Review or Surge in Short-Term Health Plan Enrollment? Experts Say Impact Limited
As Medicaid eligibility reviews approach, short-term health plans may see an enrollment wave. Experts point out that expanded ACA subsidies and special enrollment periods will cushion the impact, but misleading marketing and states that have not expanded Medicaid remain concerns.
FTC's Enforcement Action Against GoodRx Reveals New Regulatory Threats: Should Digital Health Apps Be Concerned?
The U.S. Federal Trade Commission's (FTC) enforcement action against digital health company GoodRx, marking the first use of the Health Breach Notification Rule (HBNR), signals an impending regulatory storm over the sharing of sensitive medical data. This article analyzes the impact of the rule, the FTC's enforcement strategy, and the compliance risks for digital health companies.
How Technology Reshaped the U.S. Healthcare Landscape in 2023
In 2023, health tech investment became more rational, telehealth pivoted to chronic disease management, AI applications are expected to see high-quality evidence, and cybersecurity and privacy protection became focal points.
Key Trends Outlook for Payers and Healthcare Providers in 2023
In 2023, healthcare providers will face challenges such as labor shortages and rising costs, and rate negotiations with insurance companies may be intense; the insurance industry outlook is neutral, but an economic recession and the end of Medicaid protections may lead to a decline in enrollment.
Advocate-Atrium Merger Faces No Antitrust Challenge: What Lies Ahead for Healthcare Competition Landscape in 2023?
In December 2022, Advocate Aurora Health and Atrium Health completed their merger, forming the fifth-largest nonprofit healthcare system in the United States, with annual revenue of $27 billion and 67 hospitals. The transaction was not challenged by the Federal Trade Commission (FTC) on antitrust grounds, becoming a typical case of cross-market healthcare mergers. Experts point out that the FTC still focuses on traditional mergers with geographic overlap, but research suggests that cross-market mergers may drive up prices. In 2023, antitrust enforcement faces the challenge of updating guidelines.
Complaints Pour In, HHS Information Blocking Enforcement Stalled by 'Complexity,' Health IT Coordinator Says
The Office of the National Coordinator for Health IT (ONC) has received hundreds of information blocking complaints, primarily from patients, but HHS has not yet finalized penalties for non-compliant providers and vendors. ONC head Micky Tripathi explained in an interview the complaint trends, enforcement complexities, and reasons for the delay in penalty rules.