Title: The mHealth Policy Conundrum: Keeping Pace with Technology Description: In the fourth session attendees will be provided an update on changes to policy which impact the mobile and wireless space. Topics addressed include finalization of the FDA Safety and Innovation Act (FDASIA) Workgroup. Other major policy changes implemented in 2014 and potential future changes over 2015 include updates to the Physician Fee Schedule, legislative efforts improving the use and definition of Telemedicine. Speakers: Robert Jarrin & Brian Balow Objectives: Identify current policy issues which impact mHealth adoption. Describe the impacts of FDA regulation. Discuss opportunities for policy improvement.

1. The mHealth Policy Conundrum:
Keeping Pace with Technology
April 12, 2015
Robert Jarrin, Qualcomm
Brian Balow, Dickinson Wright
PLLC
DISCLAIMER: The views and opinions expressed in this presentation are those of the author and do not necessarily represent official policy or position of HIMSS.

2. Conflict of Interest
Brian R. Balow, JD
Has no real or apparent conflicts of interest to report.
© HIMSS 2015

3. Conflict of Interest
Robert Jarrin, Qualcomm
Salary: Qualcomm Incorporated
Royalty:
Receipt of Intellectual Property Rights/Patent Holder:
Consulting Fees (e.g., advisory boards):
Fees for Non-CME Services Received Directly from a Commercial Interest or their
Agents (e.g., speakers’ bureau):
Contracted Research:
Ownership Interest (stocks, stock options or other ownership interest excluding
diversified mutual funds): (Ticker Symbols): QCOM, RAD, TS, GE, EFTC, SIRI, C,
LTS and various diversified mutual funds and 529’s.
Other:
© HIMSS 2015

4. Learning Objectives
1. Identify current policy issues which impact mHealth adoption
2. Describe the impacts of FDA regulation
3. Discuss opportunities for policy improvement

5. A Case Study – Scene 1
“Harry” – 42, diabetic, 20 (or so) pounds overweight, weekend
warrior athlete
Dons running gear, including “wearable” device to record length
of run, pace, estimated calories burned, etc.
Checks mobile app where records of prior workouts are stored
Checks his personal health record on his laptop to ensure that
the settings on his recently “installed” insulin pump are correct

6. Federal Landscape

7. Federal Landscape - HHS
• Responsible for implementing and enforcing HIPAA Privacy and
Security Rules
• HIPAA Privacy Rule provides individuals with specific rights with
respect to their identifiable health information (called “protected
health information”) when maintained by a health plan, a health
care provider that engages in certain electronic transactions, and
certain other entities (collectively “covered entities”)

8. Federal Landscape - FTC
• Works for consumers to prevent fraudulent, deceptive, and unfair
business practices (usually tied to privacy policy violations in IT
space)
• FTC enforces the Health Breach Notification Rule which requires
certain entities to notify consumers when there has been a breach
involving their electronic health information

9. Federal Landscape - NIST
• NIST's mission is to promote U.S. innovation and industrial
competitiveness by advancing measurement science,
standards, and technology in ways that enhance economic
security and improve our quality of life.
• The Computer Security Division, one of six divisions within
NIST’s Information Technology Laboratory, is responsible for
developing standards, guidelines, tests and metrics for the
protection of non-national security Federal information and
information systems.

10. Federal Landscape - FCC
• FCC decides which frequency bands are to be used by
different services; it establishes technical rules for the
operation of RF devices; it authorizes RF equipment as
compliant with its rules; and it authorizes users including
individuals or network service providers, as appropriate
• In health care area, the FCC authorizes a wide variety of RF-
based medical devices including both implanted devices (e.g.,
heart pacemakers) and patient monitoring devices (e.g.,
wireless telemetry)

11. Federal Landscape - FDA
• FDA has a public health responsibility to oversee the safety and
effectiveness of a small subset of mobile medical applications that
present a potential risk to patients if they do not work as intended
• The FDA has defined “mobile medical applications” and in
February of 2015 provided updated guidance on the regulation of
those applications

12. • Privacy and Data Security Breaches (HHS;
FTC)
• Unauthorized use of PHI (HHS; FTC)
• Medical Device Clearance and Compliance
(patient safety concerns) (FDA)
Federal Landscape – Requirements and
Risks

13. • HHS innovation grants aimed at healthcare technology
development (through its “Open Government Plan”)
• FDASIA Workgroup – FDA, FCC, ONC (to “inform the
development of a report on an appropriate, risk-based regulatory
framework pertaining to health information technology including
mobile medical applications that promotes innovation, protects
patient safety, and avoids regulatory duplication.”)
• OCR has stepped up enforcement of HIPAA violations; 2015
audit plan pending
• HHS promoting use of NIST encryption methods in connection
with HIPAA Breach Notification Rule
Federal Landscape – Cooperation?

14. • Medical malpractice
• Eprescribing requirements
• Licensure requirements
• Credentialing and privileging
• State data breach notification laws
• State consumer protection laws
State Legal and Regulatory Landscape

15. Interstate Medical Licensure Compact
• The practice of medicine is defined as taking place where the
patient receives care, requiring the physician to be licensed in
that state and under the jurisdiction of that state’s medical
board.
• Regulatory authority will remain with the participating state
medical boards, rather than being delegated to an entity that
would administer the compact.
• Participation in the compact is voluntary for both physicians
and state boards of medicine.

16. Interstate Compact, Cont’d
Blue: Enacted; Yellow: Introduced; Grey: No Status

17. Case Study – Scene 3
En route to hospital, EMS wirelessly transmits vital signs to ER
Upon arrival at ER, on duty nurse transmits Harry’s EHR and data received from
EMR to on-call resident
During examination, resident initiates video consultation with Harry’s primary care
physician, who is enjoying herself at Mardi Gras
Following consult, resident e-prescibes a new dosage of insulin to correct Harry’s
condition

18. Scene 3 Implications
Wireless transmission of vital signs to ER
Internal tranmission of Harry’s EHR and other data to resident physician
Video consult with primary care doc across state lines
E-prescribing

19. Questions
• Use this as your last slide
• Add speaker contact information and Twitter handle, if available
• Company logo(s) can be placed on this slide