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Demystifying the New Prescription Drug Use-Related Software Framework

Authors: Martin Culjat, PhD , Kory Dillman​ and Scott Kellogg The Food and Drug Administration (FDA) unveiled its draft guidance on Regulatory Considerations for Prescription Drug Use-Related Software (PDURS) in September 2023. The document shed light on how the…

Harnessing the Commercial Promise of Prescription Drug Use-Related Software (PDURS)

The FDA’s draft guidance on Prescription Drug Use-Related Software (PDURS) offers pharmaceutical manufacturers a novel strategy to enhance a drug’s label by enabling an HCP to prescribe software alongside the drug at the HCP’s discretion. The…

An Impactful Year for Global Regulation of Digital Health

2023 was a busy year with FDA and EU advancing key initiatives focused on AI/ML, cybersecurity, global harmonization, real-world evidence, and pharma companion apps…and more is coming in 2024. While 2023 brought its share of challenges…

Commercializing Digital Health as Durable Medical Equipment: A Conversation with BearingOn.Health

Join EVERSANA’s Brian Abraham, Senior Director of Market Access and Patient Access, as he engages in a thought-provoking conversation with Adam Kaufman of BearingOn.Health. Together, they unravel the complexities surrounding digital health commercialization and reimbursement models,…

Embracing the Future: A 2024 Outlook on Healthcare and Technology Trends 

As the calendar turns to 2024, so too does the ever-evolving landscape of technology-led innovation, especially across healthcare. The coming year promises groundbreaking advancements intertwined with unique challenges. The journey forward is marked by the rapid…

The Hospital of the Future and How Data, Digital and AI Merge to Make Care Better

By Pierantonio Russo, MD, FCPP, FAAP, STS, Chief Medical Officer, EVERSANA  In the fast-paced realm of healthcare, innovation stands as the cornerstone of progress. Recently, I had the privilege to attend Frontier’s Health , a leading…

Robotics in Healthcare: Revolutionizing Patient Care

Authors: Robin Arnold, Ankit Kulshrestha, Abheek Bose, Mayur Muley, Anant Kasodekar The launch of the PUMA 650 surgical robot in the 1980s, initially employed in brain biopsy procedures, ushered in the era of medical robots.1 From…

APACMed Digital Health Reimbursement Policy Forum

Introduction The APACMed Policy Forum on Digital Health Reimbursement was held on 23 May 2023, with participants from Australia, Japan, Singapore, South Korea, Germany, France, and the UK. Several digital health policymakers, academicians, and experts from…

Position Your Future-Facing Strategy on Digital Therapeutics (DTx) in China

How can DTx resonate with current portfolios and capture incoming opportunities? Key Contributors: Robin Arnold, Executive Vice President; Jerry Song, Associate Principal; Qiwei (Alex) Li, Consultant   The article discusses the potential of digital therapeutics (DTx) in China’s healthcare…

Health Disparity Solutions Build Healthier Communities and a More Equitable Medical Landscape

Achieving equity within healthcare is a harrowing but imperative goal for the industry. Lack of safe housing and healthy food, low income, ethnicity, race, rural living and other social determinants of health (SDOH) can have a…