DIA 2023: Data Integrity and Digital Health Tech Regulatory Overview


DIA session offers an overview of the current regulatory landscape and challenges for both sponsors and regulators in achieving quality and integrity in the fast-moving area.

In this session, attendees were treated to a regulatory overview for current topics in data and digital health. Regulatory bodies worldwide, as well as pharma, are trying to get ahead of –or at least stay even with –this fast moving area.

Dane Stout, Director, Life Science Digital Transformation Advisory Services NNIT presented “How Can Digital Health Be Regulated and Still Deliver Needed Innovation?”, allowing for the top five issues pressing FDA in the digital health area are, in reverse order, cloud computing; mobile apps, wearables, sensors; data sharing integrity; cybersecurity and AI/ML.

Stout noted there approximately 24 guidances in this area, with the following highlights:

  • Using wearables, sensors and mobile apps for clinical investigations don’t require validation themselves, however, the data coming out of them must be validated.
  • Data sharing integrity and secondary uses of data will continue to be an area of focus.
  • Cybersecurity for medical devices and SaMD became a requirement on December 29, 2022, when Congress signed the Consolidated Appropriations Act.
  • AI and how the data is trained is very important to FDA and it is prioritizing that.

Outside of regulatory, there remain significant obstacles to digital health adoption. A cursory list of reasons include the need for standards; pre-competitive collaborations are beneficial but hard to maintain; intellectual property; coverage, coding, and payment for digital health technologies; value-based care and the ever-present data privacy, security, integrity and trust.

Taking a further dive into data integrity, James Francum, MBA, PMP, Chief Executive Officer, Gxp-Cc Gmbh, Germany, a regulatory compliance consultant, presented “Data Integrity Case Studies and Their Learnings for Enabling a Data-Driven Future.” Data integrity is the backbone of life sciences and health care industries. And while data integrity becomes the old news during hype cycle, data integrity is always there with the goal to keep sponsors from preventing harm to patient, to provide objective evidence, and respond to regulatory inquiries.

Francum reminded the audience that to achieve consistent data integrity, the foundations are are process, systems, procedures, people, and culture—all working in in harmony.

Meanwhile, regulators are trying to get to a roadmap on data integrity and as many do, the follow the ICH, which presents global thinking on how to harmonize guidances. In the quality data space, the most recent ICH Q9 (R1) is based on Quality Risk Management. Which Francum described as the goal to “get away from decisions made on bias or feelings and, rather base decisions on data and integrity, which provides the foundation for your knowledge. Evidence-based decision making.”

Vigilant oversight is terminology presented by ICH since December 2022, which means sponsors need to ensure their process is under control. So while warning letters are the road to compliance, regulators literally outlining what you need to do to address a situation, ICH is the roadmap for country regulators, to see what is coming down the pike .

Reference: Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance, Monday, June 26. DIA 2023, Boston.

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