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

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…