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Alberta Spreafico, Ph.D, MBA

Managing Director, Digital Health & Innovation, Healthware Group, an EVERSANA INTOUCH Agency


Digital Health, Digital Technology

Alberta is a health innovator, global health and digital health expert with 10+ years of experience as senior director, researcher and management consultant in the health and life sciences sector. She co-founded and directed multiple global health innovation programs worldwide, effectively integrating digital health technologies across healthcare systems, care pathways and clinical protocols to enhance quality, access, and sustainability of care.

As Managing Director of Digital Health & Innovation at Healthware Group, Alberta leads strategic advisory services and multistakeholder programs enabling the systemic integration and adoption of digital health innovations and clinically-validated digital medical devices across healthcare systems. She also leads Healthware’s commitment as Knowledge Partner on DTx Policies in Europe for the Digital Therapeutics Alliance and for the APACMed Digital Health Reimbursement Alliance.

Alberta is a TedX speaker on enhancing access to quality care worldwide, author of multiple scenario and strategic analyses, scientific publications, and policy recommendations. She is also Adjunct Professor of Development Economics and Social Policies at the University of Pavia (Italy); scientific committee member of the Italian Digital Health Association (ASSD) and member of the external advisory board of the European Health Data Space HealthData@EU Pilot.

Articles by Alberta Spreafico, Ph.D, MBA

The Looming Legacy of Software as a Medical Device (SaMD) Misclassification Under Medical Device Directive (MDD)

Regulation (EU) 2017/745, the Medical Device Regulation (MDR), sent shockwaves through the industry with its stricter oversight and transparency demands. While the implementation challenges like delays, notified body capacity, and EUDAMED implementation have dominated discussions, a potentially bigger issue lurks for software as a medical device (SaMD) previously classified as Class I under the Medical […]

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