This document discusses the opportunities and challenges presented by mobile health (mHealth) technologies. It notes that mHealth enables new connections between people and information that can improve care, but raises issues around reliability, security, privacy, and relationships. Standards are needed to address device function, information transfer, security, privacy, and other areas. Determining who sets these standards and how outcomes should be evaluated presents challenges. The roles and responsibilities of various stakeholders in this new landscape require clarification.

1. mHealth- new opportunities, new questions Medicine 2.0 Stanford University September 2011 Barbara B. Mittleman, M.D. Director, Public-Private Partnership Program National Institutes of Health mittlemb@mail.nih.gov http://ppp.od.nih.gov

2. Mobile technology New connections: People to people e.g., case management People to information e.g., reference material, health education Information to people e.g., remote monitoring Social Media make new connections, mobile technologies make new connections. New connections means new relationships and new challenges….

3. But… issues and questions ? Reliability Device- QA/QC Communication- voice, text, image Coverage- cost, availability ? Security Confidentiality- HIPAA Hacking/unauthorized access- cybersecurity ? Privacy Personal- right to privacy and/or desire for privacy System- data use for proprietary purposes

4. Relationships New ways of interacting Person to person via the device Person to device Automation New amount of information More information ? Different information New flow of information More often, more continuous Do we know what to do with this?

5. Standards Device function- analytical and performance standards Information transfer- speed, timing, auditing Security-device security, information security, transmission Privacy-societal and/or personal standards, legal rights Use- when, how, in what conditions and/or circumstances, data analysis and transformation, algorithms, coordination with other data sources, automated responses and interactions Payment- public, private; ?dependent on geography and/or SES Regulation-FDA, FCC, CMS, other? Evaluation-what outcomes and what parameters?

6. Standards (2) Who is responsible for setting and enforcing standards? How should these be assessed and refined? What outcomes are we seeking?

7. Roles Who does what? Who is responsible for what? Who is supposed to keep tabs on the information? On the patient? On the outcome? On the cost? What if the patient is responsible and cannot undertake that responsibility? What if the systems can’t talk to one another? How to customize?

8. Recap: the challenges New relationships New data flows Coordination of people, information, and responses Outcome assessment Cost assessment

9. NIH’s view: PPPs forSynergyand the Public Health Enhance regulatory decision making; Improve public health Improve Public Health; Opportunities presented by science FDA NIH PARTNERING FOR THE PUBLIC HEALTH Improve patient care; Improve public health; reduce cost Expedite delivery of devices and services PUBLIC INDUSTRY Alignment of business practices and overlap of mission are necessary for the parties to engage successfully. More petals on the diagram can represent more interests…