Around the Globe

Accelerating Use of Healthcare Data
Asia-Pacific Digital Health and Data Consortium
Fabio Bisordi, Gracy Crane, Finny Liu
Roche Pharmaceuticals
Dorothee Grimaldi
Merck Sharpe and Dohme
Ellen Sem, Vicky Han
Johnson & Johnson
Helene Sou
Takeda
ADDC Consortium
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group of industry partners have formed the APAC Digital Health and Data Consortium (ADDC) to serve as a platform for collaboration between industry and other organizations such as policy think tanks and regulators to shape digital health data frameworks in the APAC (Asia-Pacific) region.

Over the past few years, we have observed several notable shifts in the potential to deliver patient-centered healthcare across the world. First, we have seen the rapid rise in the use of digital technologies in various areas of our lives, including digital healthcare (which combines ways of addressing healthcare needs by digital technology). This is specifically a fast-growing area across Asia, created by the opportunity to use digital health technologies, or DHTs (as defined by the FDA), and solutions to address chronic disease, aging, and other population healthcare issues.

In addition, there has been rapid digitalization of healthcare, resulting in new sources of data emerging across the world. Consequently, health data is increasingly being generated outside clinical trials, which is also referred to as real-world data (RWD). These RWD sources encompass a wide array of inputs ranging from electronic health records (EHRs), insurance claims and administrative databases, and patient registries, to wearables and in-home monitoring, health survey data, and beyond. Finally, the COVID-19 pandemic accelerated our knowledge of how digital health and data from these digital health tools and digitalization can be used to monitor and address population healthcare needs.

For efficient (or optimal) use of digital healthcare, a key driver is the creation of frameworks for digital health technologies and solutions. Therefore, it is encouraging to see organizations such as APACMed create materials that may help drive the creation of a fit-for-purpose regulatory framework for digital health across the APAC region for device regulators. However, we also need to ensure that regulatory frameworks are in place that address healthcare data policies. This will allow us to utilize digitalized data sources (such as RWD) as well as data from digital health tools for downstream uses (e.g., using digital measures to develop novel endpoints for clinical trials, etc.).

With these new sources of data, it is important to draw a distinction between digitalized data (e.g., electronic health records) and data from digital health tools. Generally, digitalized data is considered “static” (i.e., there is usually a time lag between data collection and data availability for analysis), whereas data from DHTs can be considered “continuous,” because it can be available in almost real time. This continuous stream of data may provide the opportunity to demonstrate real-time performance data which can greatly enhance our ability to address healthcare needs quickly and allow us to measure variables (e.g., via sensors) that we were not able to measure before. As with the use of any type of data by regulators, we need to ensure that implementation of such regulatory frameworks will enable utilization of these types of data.

However, uptake of digital health and implementation of healthcare data policies differ significantly across ASEAN countries. The adoption of digital health innovation and collaborations throughout Southeast Asia and the wider Asia-Pacific region seems to vary. Other issues include the lack of streamlined regional healthcare data policies and the rapidly changing healthcare data environment, both of which hamper drafting policies for interoperability in a timely manner. The ADDC has been formed to address this gap.

Vision, Mission, and Establishment of ADDC

The vision of ADDC is to ensure that the regulatory frameworks are available and fit for purpose for addressing challenges and opportunities in using data from digital health tools and digitalized sources (referred to as “digital health data” for the rest of the article). This will establish healthcare that is more empowering and accessible for patients, more efficient for healthcare providers, and more cost-effective for health systems. In addition, it provides industry with the promise that using such types of emerging data will optimize R&D processes and enable more patient-centric trials through using digital tools and endpoints.

ADDC has outlined specific near-term and midterm objectives with this vision in mind:

  • To establish ADDC as the leading industry consortium playing a key role in shaping use of digital health data within this region
  • To help shape or co-create regulatory frameworks as needed to enable use of digital health data by regulators in this region and beyond

Created in 2020, the consortium currently consists of four industry partners (Johnson and Johnson, Takeda, Merck Sharpe and Dohme, and Roche Pharmaceuticals) that have a significant footprint in this region. We envisage working with multiple stakeholders such as policy think tanks, academia, patients, healthcare professionals (HCPs), and regulators to drive toward our objectives. The figure below highlights numerous opportunities available through the creation of such a consortium.

Created by ADDC members to highlight the various opportunities available through the creation of this consortium.
Figure 1: Created by ADDC members to highlight the various opportunities available through the creation of this consortium.

Achievements of ADDC: 2020-2021

The consortium has worked with the Duke-NUS Centre of Regulatory Excellence (CoRE) to focus on enabling digital health adoption in the APAC region. One of the first activities was a November 2020 round table with stakeholders including APAC health ministries and regulatory authorities, as well as academics, nongovernmental organizations (NGOs), and industry. This engagement led to publication of a white paper on Digital Health Adoption in Asia Pacific which identifies key enablers and recommendations for adoption of digital health in the region (shown below).
White Paper

Plan for 2022-2023 and Call for Additional Partners

ADDC will release its work plan later in 2022, will continue its collaboration with Duke-NUS CoRE, and plans to delve more deeply into policies, such as regulatory acceptance of RWD, needed for the use of digital healthcare data and digitalized data sources. In addition, ADDC is interested in working with other interested stakeholders on additional topics, such as data interoperability and privacy, that will enable better use of digital health data, through collaborations and pilots. (Please reach out to this publication to express interest.)

Conclusion

Changes in the healthcare ecosystem brought about by digital health technologies and digitalization of data have highlighted the need for highly collaborative approaches to create platforms where diverse stakeholders can work together to use these technologies and data to deliver value to patients and society. We believe the work of this consortium will add value to this ecosystem through initiatives aimed at:

  1. Shaping the regulatory environment to enable the use of DHTs and tools, and digitally derived data, for product development and regulatory decision making; and
  2. Fostering efficient and patient-centric drug development through use of digital healthcare data.

Acknowledgements: The authors thank the following additional contributors to this project: Sannie Chong (Roche Pharmaceuticals) and MayLi Woon (Sanofi).

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