Legal and Business Guide to

mHealth and Wireless Medical Technology

Monday, April 29 to Wednesday, May 01, 2013
Washington Plaza Hotel, Washington, DC
​Main Conference - Day One | Monday, April 29, 2013

12:30 Registration

1:15 Co-Chairs’ Opening Remarks


Robert Jarrin
Senior Director of Government Affairs
Qualcomm Inc. (Washington, DC)

Robert B. McCray
President & CEO
Wireless-Life Sciences Alliance (San Diego, CA)

1:45 Spotlight Address: Fostering Innovation in Health Information Technology and Wireless Health: Removing Barriers and Promoting Entrepreneurship

Ahmed R. Bhadelia

Senior Advisor, Office of Congressman Mike Honda
(CA-17)

• Promoting front-loading capital investment
• Addressing regulatory barriers
• Creating a marketplace
• Developing a trained workforce

2:30 Federal Communications Commission Update

Julius P. Knapp II
Chief, Office of Engineering Technology
Federal Communications Commission (Washington, DC)

“You can’t argue with physics” – there is a finite amount of spectrum and everyone wants in. The FCC has made its intent to support the use of wireless medical technology clear though the assemblage of its mHealth Task Force and negotiations with industry. Be in the audience as Julius Knapp holds forth on major developments, current efforts, and what you can expect next in terms of managing interference, sharing the spectrum, and increasing capabilities to improve access. Points of discussion include:

• Fine tuning medical body area networks (MBANs)
• Changing the rules for Experimental Licensing

3:15 Afternoon Networking Refreshment Break

3:45 Working with Government Bodies In a Health Information Technology World


David Muntz, MBA
Principal Deputy National Coordinator
Office of the National Coordinator for Health IT
(Washington, DC)

Yael Harris, PhD, MHS
Director, Office of Health IT & Quality
Office of Special Health Affairs
Health Resources & Services Administration
(Rockville, MD)

Thomas Novak (Invited)
HITECH Coordinator, Centers for Medicare & Medicaid
Services, U.S. Department of Health & Human Services
(Philadelphia, PA)

Kerry McDermott, MPH
Senior Director, Health Care Technology Policy
West Health Institute (Washington, DC)

Alice Borrelli
Director, Global Healthcare Policy
Intel Corporation (Washington, DC)

Bruce A. Olcott
Partner
Squire Sanders (Washington, DC)

Moderator:
Robert Jarrin
Senior Director of Government Affairs
Qualcomm Inc. (Washington, DC)

This panel will present a discussion between agencies and industry regarding ongoing developments and negotiations with respect to the widespread implementation of wireless medical technology. Topics will include:

• Discussing the MOU
• Discussing each agency’s specific guidance documents
• Expectations regarding the creation of coordinator positions for MBANs
• Evaluating the impact of the petition for reconsideration and the evolution of the final   rules

5:15 Audience Q&A Open Forum for Discussion on the New Frequency Coordination Efforts and the Impact on Life Sciences Companies

5:45 Conference Adjourns to Day Two


Day Two | Tuesday, April 30, 2013

8:00 Continental Breakfast

8:45 Co-Chairs’ Opening Remarks and Recap of Day One

9:00 Bring Your Own Device (and Extra Insurance): Overcoming Physician Liability Concerns in the Practice of Telemedicine and mHealth


Daniel Goldman
Legal Counsel
Mayo Clinic (Rochester, MN)

Joseph P. McMenamin
Partner
McGuireWoods (Richmond, VA)

• Defining “telemedicine”
• Spotting the federal and state law implications of remote diagnosis and treatment
      o licensing issues incurred when practicing telemedicine across state lines and     strategies to counter them
• Limitations to standard commercial insurance and alternative coverage options
• Creating a safety net for adverse events
• When is informed consent required for the transmission of patent information via a mobile device?
• Defining the obligations of physicians to respond to text messages and e-mails from patients
      o liability for clinicians who receive information and act inaccurately or fail to act
      o standard for misuse of devices during self care
• Complying with the Stark Act and the FederalAnti-Kickback Statutes

10:15 Morning Coffee Break

10:30 Diagnosing and Treating Privacy and HIPAA Concerns


Cora Tung Han
Attorney, Division of Privacy and Identity Protection
Federal Trade Commission (Washington, DC)

Julee Thompson
Chief Healthcare Executive
Sprint Nextel (Overland Park, KS)

Deven McGraw
Director of the Health Privacy Project
Center for Democracy and Technology (Washington, DC)

Adam Greene
Partner
Davis Wright Tremaine (Washington, DC)

Moderator
W. Andrew H. Gantt III

Partner
Cooley LLP (Washington, DC)

• Overview of HIPAA regulations
      o understanding which statutes apply to your use of health information
        - disclosures; exceptions; accountings
      o identifying HIPAA covered entities
      o FTC requirements for data integrity
• Analysis of how regulations have been enforced
• Discussion of complications that have arisen
      o use of e-mail and social media relative to health information technology (HIT)
      o desire for access to data sets
      o analysis of HIPAA research rules
      o separating false fears from actual risks of data compromise
      o discussing the OCR inventory of breaches
• Review of solutions
      o challenges and benefits of seeking informed consent
      o achieving anonymization
      o avoiding HIPAA in the delivery of mobile health services
• Nailing down individual privacy protections
      o encryption
      o ensuring parameters around the device
      o securing the flow of information
      o adjusting patient matching
      o creating policies that support Bring Your Own Device without sacrificing privacy
      o developing internal policies that cover the company’s HIPAA obligation while allowing consumers accessto their PHI

• Parsing examples of HIPAA Compliant Text Messages
• Recognizing who has access to data and what agreements should be in place
      o hospitals; cloud servers; consumers

12:00 Networking Luncheon

1:30 Safeguarding Your Data While Minimizing the Risk of Security Breaches


David Hoglund
President and Founder
Integra Systems, Inc. (Suffield, CT)

Dennis M. Seymour, CISSP, ITIL
Chief Security Architect
Ellumen, Inc. (Arlington, VA)

Lee Kim
Attorney, Chair of the mHIMSS Legal/Policy Taskforce
Tucker Arensberg, P.C. (Pittsburgh, PA)

• Securing wired and wireless networks
      o addressing network security loopholes
      o authentication methods
      o encryption of data in transit
• Securing mobile devices and information systems
      o authentication methods
      o securing firmware, operating systems, and applications
• Securing data in the “cloud”
      o audit standards (e.g., SSAE16)
      o third party certifications (e.g., FedRAMP)
      o encryption
• Securing mobile devices
      o preventing loss of mobile devices
      o encryption of data
      o mobile device management
• Hacking medical devices: myth or threat?
      o tampering with or disabling device functions
      o unauthorized acquisition of medical information
• Weighing risk management approaches and determining the most efficient use of resources
      o allocating liability exposure among parties
         - clauses to limit liability; disclaimers
      o applying iso80001 standard
      o ensuring a device works as intended
• End user training
      o promoting a culture of security
      o making users aware of best practices
• End of life cycle
      o destruction of data
• Emerging threats
      o viruses and malware
         - machine-made viruses and malware
• Social media as new avenues of distribution for viruses and malware
      o phishing
• Cybercrime
      o Computer Fraud and Abuse Act; wire fraud
      o involving law enforcement

2:45 Bridging the Digital Innovation and Regulatory Divide: Bringing Mobile Apps to Market in a Compliant and Timely Manner

Kyle Peterson
Director, Regulatory & Corporate Affairs
Calgary Scientific Inc. (Calgary, AB, Canada)

Matthew A. Kaminer
General Counsel & Secretary
Epocrates, Inc. (Ewing, NJ)

Bradley Merrill Thompson
Partner
Epstein Becker & Green, P.C. (Washington, DC)

Many application developers are struggling to reconcile their business goals with the regulatory oversight affecting medical devices. This panel will forecast the front-runners in the race to develop the hottest new health application in light of the evolution of the FDA’s treatment of mobile health applications. It will then examine how companies are balancing the FDA’s initial regulatory guidance and the first set of clearances issued to
this exciting field of products to provide practical guidance on:

• Industry overview: what products have experienced sustained growth?
      o wellness; lifestyle; diagnostic
• Where is the industry heading?
      o medication dispensing
      o use of algorithms to diagnose
• Understanding what applications need FDA approval
• Establishing a predicate device for a novel mobile medical app
• Analyzing how software is regulated by the FDA
       o when registration as a mHealth supplier is necessary
• Advice on working with the FDA from companies that have successfully gained clearance

4:00 Afternoon Coffee Break

4:15 Adopting a Strategic Approach to Ensure Reimbursement for mHealth Products and Services

Jennifer Covich Bordenick

Chief Executive Officer
eHealth Initiative (Washington, DC)

Paul Sheils
Managing Director
Ansley Capital Group, LLC (Newtown, PA)

Shahid Shah, MSTM
Chief Executive Officer
Netspective Communications, LLC (Landover, MD)

The Medicare Incentive Payment Program is offering $36 billion through new policies and regulations to incentivize health care practitioners to adopt heath information tech. This panel of experts will walk you through some of the basic questions surrounding this complex and essential theme before delving into a discussion of current trends.

• Classifying reimbursements for telemedicine
• Evaluating the coverage of e-prescriptions
• Navigating the qualification process
      o obtaining a CPT code
• Meeting the standard for durable medical equipment (DME)
• Exploring the impact of the emerging value-based reimbursement models (e.g., meaningful use, ACOs, PCMH, P4P) on payment status and implementation of wireless technologies
• Examining how 30 day readmission is driving utilization of wireless medical technology in the home

5:30 Main Conference Concludes