2021 Trends: Digital Transformation in Healthcare Webinar (by Sierra Labs)

This webinar, hosted by Sierra Labs, provides an in-depth analysis of the accelerated digital transformation in healthcare driven by the COVID-19 pandemic, focusing on its implications for life sciences companies, regulatory bodies, and healthcare equity. The discussion features insights from industry leaders: Aubry Kelly (CEO of Rabble Health, with 15 years of pharma experience at Amgen), Kwame Olmer (Principal at Olmer Ventures, a seasoned regulatory expert and former FDA official), and Ricardo Barrios (Managing Partner at Natural Bridges Ventures and CEO of Adhera Health, an experienced healthcare investor). The central theme is how the sudden shift to digital operations has exposed systemic vulnerabilities and created new opportunities for innovation, particularly in compliance, data management, and patient access.

The panelists agreed that the industry was moderately to poorly prepared for the surge in digital operations and regulatory workload. Kwame Olmer noted that the FDA’s workload effectively doubled overnight due to the influx of Emergency Use Authorization (EUA) applications, straining resources and leading to inevitable delays in traditional application timelines. Ricardo Barrios highlighted the massive increase in telehealth usage—a 150% increase in the first few months of 2020, with 40% of all visits remaining virtual throughout the year. This rapid shift necessitates a fundamental reassessment of business models, focusing on core value proposition, appropriate technology leverage, and strategic partnerships to coordinate care effectively.

A significant portion of the discussion centered on data integrity and regulatory compliance in the digital age. The speakers emphasized that in the post-pandemic landscape, stringent adherence to data protection standards like HIPAA and GDPR, alongside quality management systems (QMS) such as ISO 13485, is shifting from a "nice-to-have" to a "need-to-have" for digital health companies seeking investment and market trust. Kwame Olmer noted that while personal privacy standards (HIPAA) have not been lessened, the FDA has increased public sharing of performance data for critical diagnostic devices (like COVID tests) to promote transparency. The emerging trend for medtech companies is a two-step process: developing a lower-regulated Minimum Viable Product (MVP) under enforcement discretion, gathering data, and then building highly regulated features with defensive modes (e.g., De Novo or Breakthrough Designation) to secure market position.

Looking ahead to 2021 and beyond, the panelists identified key emerging trends. Aubry Kelly stressed the necessity of industry-wide partnerships—moving from a "swim team" to a "crew team" mentality—to democratize information and address health disparities. Ricardo Barrios focused on technological advancements, particularly the rise of AI-driven platforms and the critical need for interoperability among Electronic Medical Record (EMR) systems to lower the cost of access to good health. He also highlighted the often-overlooked aging population, noting that seniors are increasingly adopting digital tools and wearables as a means to maintain independence, challenging the fallacy that this demographic is technology-averse. The ultimate goal for the industry must be a holistic view of the population, ensuring that digitalization serves to close equity gaps rather than widen them.

Key Takeaways:

• Regulatory Workload and Strain: The pandemic dramatically increased the FDA's workload, particularly for EUA applications, leading to acknowledged strains on resources and delays in meeting typical application timelines for non-COVID-related submissions.
• EUA as a Double-Edged Sword: While Emergency Use Authorization provides a faster path to market on paper, the practical reality of the surge in applications means the process can still take months due to necessary clarifications and back-and-forth with the FDA.
• Compliance is a Necessity, Not a Luxury: For digital health companies, robust data protection (HIPAA, GDPR) and quality management systems (QMS, ISO 13485) are now mandatory components for attracting investment and ensuring patient trust, moving beyond being merely "nice-to-have."
• Two-Step Regulatory Strategy: A successful playbook involves launching a lower-regulated MVP (potentially under enforcement discretion) to gain market exposure and data, followed by developing highly regulated features (e.g., De Novo or Breakthrough Designation) to establish a defensible market position.
• Interoperability is Crucial for Cost Reduction: The future of digital health relies on EMR companies opening up their systems to integrate with digital therapeutics and health platforms, which will lower the overall cost of providing quality healthcare and improve patient access.
• Focus on Health Equity: Digital transformation must actively address health disparities. Companies should be intentional about targeting underserved populations (e.g., lower-income areas, specific racial groups) to ensure technology democratizes access rather than creating a further digital divide.
• The Aging Population is Tech-Forward: Contrary to common misperception, the senior population (65+) is increasingly adopting digital tools and wearables, viewing them as essential vehicles for maintaining independence; solutions must be designed with this demographic in mind.
• Post-Pandemic Compliance Changes: The FDA has learned that it can iterate on guidances at a much higher cadence, which is expected to lead to quicker promulgation of guidance, particularly for the digital health sector, though some emergency guidances will be phased out.
• Strategic Partnerships are Essential: No single company holds the "golden ticket." Improving patient outcomes requires the entire ecosystem—pharma, providers, payers, and digital health firms—to engage in appropriate partnerships and work collaboratively.
• The Ripple Effect of Missed Care: The decline in preventative measures, screenings, and adherence to standard care during the pandemic (e.g., for cancer and strokes) will have a long-tail effect, requiring the industry to be creative in its post-pandemic response.

Tools/Resources Mentioned:

• Sierra QMS: Automated Quality Management System (QMS) offered by the host, Sierra Labs.
• Sierra Cloud: Automated cloud validation tool offered by Sierra Labs.
• AWS and Atlassian Jira: Mentioned as partners of Sierra Labs, suggesting their use in QMS and project management.
• Veeva CRM: (Implied relevance, though not explicitly mentioned by panelists, as it is a core platform in the pharma commercial space discussed.)

Key Concepts:

• Emergency Use Authorization (EUA): A mechanism used by regulatory bodies (like the FDA) to expedite the availability of medical products during public health emergencies, often requiring less traditional validation data.
• Digital Therapeutics (DTx): Software-driven interventions that deliver evidence-based therapeutic interventions to prevent, manage, or treat a medical disorder or disease.
• Interoperability: The ability of different information technology systems and software applications (e.g., EMRs) to communicate, exchange data, and use the information that has been exchanged.
• GDPR (General Data Protection Regulation): European regulation governing data protection and privacy, often serving as a benchmark for stringent data compliance globally.
• ISO 13485: An international standard specifying requirements for a comprehensive quality management system for the design and manufacture of medical devices.