Data Privacy as a Hurdle or Enabler for Digital Health Implementation? The Legal Framework

April 7, 2022

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Title: Data Privacy as a Hurdle or Enabler for Digital Health Implementation? The Legal Framework

Thursday, April 7, 2022 
12:00PM EDT | 4:00PM UTC | 6:00PM CEST

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Background: The key success factor for digital health implementation is the information sharing across multiple stakeholders engaged in the clinical decision making. The COVID pandemic revealed numerous differences in how individual data are used in the process of the adoption of various digital health solutions in the healthcare systems across the globe.

Although we observe unprecedented increase in the use of telemedicine services across jurisdictions, the speed in the adoption of other digital health solutions in post-COVID era varies geographically. Digital transformation allowed faster development of technologies powered by growing amount of health and behavioral data collected directly from patients. The general public trust issue has been on agenda across jurisdictions as many are simply not confident of the data security and its usage.

With new data privacy regulations emerging in the European Union, Asia, Latin America, and North America it is important to discuss the sensitive trade-off between openness and security restrictions with the implementation of data powered health technologies to inform pricing and reimbursement (P&R) decision making. The accelerated speed with the adoption of digital health solutions brought the sense of urgency for P&R bodies to establish a new modus operandi that will allow to strike that sensitive balance.

The webinar will review:

• Current legal framework in both EU and USA that defines the regulatory pathway for digital health solutions will be presented. 
• Panel discussion about the challenges with the P&R assessment of such technologies within current legal settings.  
• List of recommendations for P&R standards for assessment of digital solutions with respect to the data utilization will be elicited

Best practice sharing approach will be the guiding principle.

As the outcome of the debate, the overarching conclusion will be drawn how to strike the balance between openness and security in the process of data collection for the successful P&R decision making process regarding digital solutions.

Data privacy as a hurdle or enabler for digital health implementation? A Series of 4 webinars developed quarterly during 2022. Each webinar will focus on a particular stakeholder perspective (legal, manufacturers, patients, etc.) with a final wrap up to review the implications and opportunities for professionals on HEOR.

Learning Objective:

• Understand the legal frameworks and regulation applicable for patient data management. (Data privacy, Data security, HIPAA, and additional international regulatory frameworks) from a multistakeholder perspective.


Katarzyna Kolasa, PhD,
Professor Health Economics, Kozminski University, Warsaw, Poland


Bakul Patel, MSEE, MBA,
Director, Digital Health Center of Excellence, FDA, Washington, DC, USA

Andrzej Rys,
Director, Health Systems, Medical Products and Innovation, Directorate General Health and Food Safety (DG SANTE), European Commission, Belgium

Paul Bridges, PhD, Senior Vice President, Worldwide Head of Regulatory & Access, Parexel, Dublin, Ireland

Brought to you by: ISPOR Digital Health Special Interest Group

Please note:
On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar.

Reservations are on a first-come, first-served basis.

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