Health Citizenship: The Nexus of Data, Technology and Research

• Core Concept: The panel introduces "health citizenship," defined as a shift from a one-directional healthcare model (provider to patient) to a two-way dialogue where consumers and patients actively engage with research and care systems.
• Source Data: This concept emerged from interviews with over 150 senior stakeholders in the biomedical research and healthcare ecosystem conducted prior to the 2020 presidential election.
• Strategic Recommendations: Faster Cures published a report detailing seven key recommendations covering the regulatory system, patient centricity, translational research, clinical trials, and data access.

Panelist Perspectives and Case Studies

• Kaiser Permanente (Bernard Tyson):

  • Health Determinants: The organization operates on a model where 40% of health is determined by behavior, 30% by genetics, 20% by "place" (community infrastructure), and only 10% by episodic health care.
  • Virtual Engagement: In the preceding year, 52% of approximately 100 million patient encounters (primary care, etc.) were conducted virtually via phone, secure messaging, or video conferencing.
  • Equity vs. Equality: The narrative has shifted from "equality" (uniform access) to "equity" (tailored resources to raise outcomes for specific populations).
  • Concrete Action: A Mid-Atlantic initiative successfully reduced high blood pressure rates in the African-American population to match majority population levels by utilizing community access points like barbershops, beauty shops, and churches, rather than relying solely on clinic visits.
  • Mobile Health: The organization is deploying mobile vans directly into underserved communities to increase access and leverage cell phone technology for proactive communication.
  • Physician Productivity: The panel proposes redefining physician productivity metrics beyond time-per-patient to account for data synthesis, team-based management, and virtual visit satisfaction.

• Smart Patients (Ronnie Zeiger):

  • Patient Connection: The platform aims to facilitate peer-to-peer support, noting that social connectedness is a predictor of breast cancer recurrence and mortality independent of other factors.
  • Clinician Gap: National data suggests only roughly 0.33% (one-third of one percent) of clinicians have introduced one of their patients to another, indicating a massive untapped resource in patient networks.
  • Future Informed Consent: The organization hypothesizes that in 10 years, part of informed consent for procedures may include speaking with a peer who has already undergone the procedure.

• All of Us Research Program (Stephanie Devaney):

  • Study Scope: The program is building a cohort to longitudinally track diverse factors (genetics, environment, lifestyle) to understand both disease progression and the mechanisms of staying healthy.
  • Engagement Strategy: Leveraging technology (smartphones) to scale engagement strategies beyond the limitations of the Framingham Heart Study, which relied on single-location, face-to-face interactions.
  • Data Feedback: The program intends to return actionable genetic results to participants, though full raw genomic data will be available only upon request to manage the "mass of data" issue.
  • Diversity Goal: A primary objective is enrolling a diverse population that accurately represents the demographic actions of the United States.

• 23andMe (Joyce Tung):

  • Research Incentives: Surveys indicate that the primary incentive for individuals to participate in large-scale studies is receiving personal health information back from their DNA.
  • Data Curation: The company focuses on curating reports to ensure over 90% of users across all educational strata can understand the findings, rather than providing unprocessed whole-genome data which may contain non-actionable information.
  • Community Recruitment: The organization observed high enthusiasm for participation in research studies, driven by altruism and a desire to help others, countering the assumption that clinical trials suffer from recruitment difficulties.

• Fitbit (Eric Friedman):

  • Data Utility: Continuous monitoring has led to life-saving interventions, such as detecting abnormal heart rates that prompted users to seek emergency care.
  • Behavioral Modification: Adding a friend to a Fitbit network increases step counts by an average of 700 steps per day (approximately 2.5 miles per week).
  • Clinical Application: Fitbit is collaborating with UCSF on a study to improve the health of patients on liver transplant waiting lists by using biometric data to build treatment plans that reduce morbidity prior to surgery.
  • Continuous Care: The device aims to provide coaching and reminders for the 364 days between annual doctor visits to support lifestyle changes like A1C reduction.

Regulatory, Privacy, and Systemic Challenges

• Data Privacy & Trust:

  • Transparency: Organizations emphasize that patient trust is paramount; consent models must be "opt-in" rather than "opt-out," with clear communication about how data is used and the value provided in return.
  • Contextual Consent: Users are more likely to share data when the context and specific benefit are clear, rather than in abstract legal agreements.
  • Security: Cybersecurity and data confidentiality are identified as critical concerns that organizations must actively manage to maintain the physician-patient trust relationship.

• Regulatory Collaboration:

  • Cultural Divide: A significant gap exists between Silicon Valley's "move fast" mentality and the FDA/NIH's risk-averse, paper-based regulatory frameworks.
  • Collaborative Approach: Successful organizations (e.g., 23andMe, Fitbit, Kaiser) advocate for working with regulators to demonstrate patient safety and modernize outdated rules, rather than attempting to bypass them.
  • Legislative Context: The 21st Century Cures Act (signed December 2016) is being tracked to ensure compliance while pushing for the modernization of the biomedical research enterprise.
  • Single IRB Implementation: The All of Us program is piloting a Single Institutional Review Board (IRB) across 60+ institutions to streamline multi-state studies, providing real-time feedback to NIH to address bureaucratic hurdles.

Future Outlook and Forward-Looking Statements

• Team-Based Care: The panel predicts an inevitable shift toward team-based management of patient health to handle the increasing volume of data and the complexity of modern conditions.
• AI Integration: The future of healthcare data involves moving from raw data to artificial intelligence that aggregates and synthesizes information to assist physicians in making better decisions.
• Personalized Medicine: Treatment and behavioral feedback will increasingly be customized based on individual genetic predispositions and unique reactions to advice.
• Systemic Evolution: Stakeholders believe the current episodic, sick-care model must be transformed into a proactive, health-maximization model, though this requires regulatory adaptation and new productivity metrics for physicians.