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Intelligently Automating Prior Authorization to Build Consumer Trust in Healthcare

Perficient: Drug Development

Health insurers are always seeking access to actionable information about their members while adhering to data privacy laws and regulations. As the saying goes, diamonds are made under pressure, and the most impactful opportunities are often those that challenge leaders the most.

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Rare Disease Day 2025: Rally for Rare Event Recap

Conversations in Drug Development Trends

On the last day of February every year is Rare Disease Day , a dedicated day to celebrate the rare disease community, including patients, families, caregivers, clinicians, researchers, regulators, and more. The response to this event from the rare disease community has been overwhelming and positive.

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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog: Biosimilars

Therefore, this guidance builds on FDAs commitment to develop and apply innovative approaches to the regulation of [AI-enabled devices]. Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026.

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Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law Blog: Biosimilars

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

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HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors

FDA Law Blog: Biosimilars

Mullen’s extensive experience and contributions to the field of in vitro diagnostic (IVD) regulation. IVD Overview and Update,” will cover recent developments in IVDs, including the proposed LDT regulation. (HP&M), the largest dedicated food and drug law firm in the U.S., This prestigious appointment recognizes Ms.

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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. These risks face fewer regulations but must meet certain standards to ensure ethical use. While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026. a synthetic control arm)?

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Health Insurer Trends to Watch at AHIP 2024

Perficient: Drug Development

.” – Mike Porter Top Trend: Transformation, Modernization, and Mandates LinkedIn | Blogs The health insurance industry is constantly changing, driven by the pressures it faces from customers, regulators, and market forces. I’ve been in this industry for over 20 years and I always want to keep learning!