The Transformation of Digital Health: What it Means for Regulatory Professionals

Feature ArticlesFeature Articles | 02 December 2019 | Citation

Articles throughout November focused on what the changing digital health landscape, including big data, means for regulatory professionals. Leaders in the digital health space shared their insight and best practices on the challenges and opportunities of implementing digital health solutions, data safety and data risk in the digital healthcare sector and global digital drug information sources. Authors presented the impact of Software as a Medical Device (SaMD) on commercial developers of devices and software, big data implications on the pharmaceutical industry and cybersecurity requirements.

Digital Health Solutions

The opportunities and challenges in technology are driving explosive breakthroughs for digital health solutions in our technologically focused society. The accessibility, convenience and mobility of digital health has created a cultural shift in the way we use, process and provide healthcare solutions. This transformational shift also has modified how one uses and obtains information from products and users in a real-world scenario, driving interest from many industries. In “Emerging Digital Health Solutions: Inherent Challenges in the Technology Driven World,” device and digital health experts, Darin Oppenheimer, George Cusatis, Suraj Ramachandran and Jessica Hale, explore the challenges of digital health solutions and emphasize the appropriate controls necessary to help mitigate risks and ensure companies are adhering to the growing needs of regulators and industry best practices.

Digital health continues to dominate private investment, political rhetoric, regulatory interest and public conversation. Though each of these contingents has different objectives, one common factor unifies them—an inability to keep up with the rate of change. 2019 marked a period where the confluence of scandal and innovation triggered the need to critically examine the impact and unintended consequences of a dynamic and relatively unbridled “big technology” sector. In “Driving Innovation, Mitigating Risk: The Path Forward in Building Consumer Digital Health and Safety Standards,” technology strategists, Nicolette Guillou, Saier Zeng and Amy Flynn, discuss issues of data safety and data risk in the digital healthcare sector. The authors cover digital health technologies and trends, issues and risks related to digital health privacy, foundational data regulations and new frontiers and strategies for building digital health governance and consumer protection.

Regulatory labeling expert, Thomas Liebers, presents the increase in digital drug information in both the US and EU as a complement to product labeling and how patients might benefit. In “Developing Digital Drug Information Based on Real World Effectiveness Tests,” the author reviews his study of digital drug information sources using patient participants who offered feedback on their experiences using web-based drug information both from the US and European Union. Topics covered in the study and reported include information on digital formats, patient trust in drug information, measures of format effectiveness, the use of graphics, print font size, website color contrast, ease of navigation, and other important aspects of presenting drug information through digital technologies.

Navigating the regulatory pathway for traditional healthcare products like drugs and devices is time consuming and complex, but relatively well understood. FDA maintains a clear role in regulation to maintain the safety of patients while enabling clinically sound innovation to improve healthcare. However, as the rise of combination products including drugs, devices, diagnostics, software and services continues, it is important to understand how FDA is responding and what the implications are for manufacturers. In “Real Innovation at FDA? Implications of a Changing Digital Health Regulatory Landscape,” digital health strategists, Greg Chittim and John Latimer, explore the history of combination product regulations in the US with a focus on the most recent FDA guidance for the regulation of Software as a Medical Device (SaMD) and the implications for commercial developers of medical devices and software.

What is big data?

The internet has provided a convenient way to share information globally and instantly. As the functionality of the internet has improved, the volume of data has increased due to data being available and processed from and by many sources. Regulatory consultant, Pravan Naidoo, tackles this complicated issue in “Big Data and its Impact on the Pharmaceutical Industry,” and clarifies “big data” and its impact on the pharmaceutical industry. The author covers several areas in which big data has had a profound impact, such as in genomics, clinical trial monitoring, clinical monitoring and pharmacovigilance. He concludes by touching on big data and its relationship to the regulatory professional.

Cybersecurity  Requirements

Advancements in medical device technology has allowed for services, initiatives and changes in healthcare delivery to evolve at a break-neck pace. Smartphones are increasingly integrated into patient care planning, providing internet connectivity to share data with Healthcare Delivery Organizations (HDOs), doctors and researchers. In “Regulatory Cybersecurity Requirements for Medical Devices,” cybersecurity expert, Vidya Murthy, discusses the relevance of cybersecurity to the healthcare industry. She reviews cybersecurity requirements presented by governing bodies and industry best practices for medical devices.

Chinese Medicine

Regulatory expert, Atara Noiade, discusses the need for continued researcher access to Chinese medicinal herbs as the need for new options to treat febrile disease increases. In “The Continued Importance of Consumer Access to Chinese Medicine in a Changing Climate,” the author cites global warming and climate change statistics as potentially responsible for the increase in tropical diseases for which traditional Chinese medicine has been used for centuries. She also reviews policies from various agencies that govern the use of such herbal medicines and supplements and concludes that keeping access open offers useful treatment alternatives.

What’s Coming in December

December feature articles will explore advertising, promotion and labeling in addition to the role of social media in regulatory communications. We have brought together some of the leading experts in the profession to share their valuable experience on a wide range of issues impacting APL professionals today. Topics will include optimizing ad/promo regulatory affairs communications, using the patient perspective, social media influencers and considerations, price transparency, DTC TV commercials and considerations for use beyond TV, Facebook chat study results and the use of hashtags. Look for these topics and more throughout December.

Contribute to RAPS Regulatory Focus

Share your experience and knowledge on the topics below:
  • The Vital Role of Regulatory Within Organizations and Throughout the Product Lifecycle
  • How to Communicate With Various Stakeholders About the Importance of Regulatory
  • Regulatory Ethics and History
  • Risk Management, Dealing With Contractors and Vendors and Mitigating Risk
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  • Policy Changes, ICH, PIC/S, Regulating Future Policies
  • Advertising, Promotion, Labeling and the Role of Social Media
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