March 28, Dear Chairman Walden:

Transcription

1 33 W. Monroe Street, Suite 1700 Chicago, IL Tel Fax March 28, 2013 Honorable Greg Walden Chairman, Subcommittee on Communications and Technology Committee on Energy and Commerce United States House of Representatives 2125 Rayburn House Office Building Washington, DC Dear Chairman Walden: In view of the House Committee on Energy and Commerce, Subcommittee on Communications and Technology s March 19, 2013 hearing on Health Information Technologies: Harnessing Wireless Innovation, HIMSS would like to submit the following information to add to the overall understanding of these important issues. HIMSS is a cause-based, not-for-profit organization exclusively focused on providing global leadership for the optimal use of information technology (IT) and management systems for the betterment of healthcare. Founded 52 years ago, HIMSS and its related organizations are headquartered in Chicago with additional offices in the United States, Europe and Asia. HIMSS represents nearly 50,000 individual members, of which more than two thirds work in healthcare provider, governmental and not-for-profit organizations. HIMSS also includes over 570 corporate members and more than 225 not-for-profit partner organizations that share our mission of transforming healthcare through the effective use of information technology and management systems. Recognizing the growing role of mobile and wireless devices in health and healthcare, HIMSS created mhimss to focus on the use of mobile and wireless technologies to promote health, improve the quality, accessibility and safety of care, and increase the cost-effectiveness of care. mhimss builds on the existing HIMSS strengths of convening stakeholders, sharing knowledge, providing world-class education, public policy, research, and content entirely focused on the use of mobile technologies. Additionally, HIMSS created the mhimss Roadmap (see enclosure) to provide guidance to professionals, organizations, corporations and health systems on the adoption of mobile and mhealth devices. The Roadmap development team included a variety of industry wide subject matter experts who volunteered their time to develop the document. The mhimss Roadmap combines up to date knowledge on how to implement mobile and mhealth best practices across a number of topics. The Roadmap is a living document and the mhimss team of volunteers will regularly post updates to reflect new industry developments. Each section of the Roadmap provides a brief background of the topic, the current state of adoption, and potential future improvements. In addition, the document discusses the interrelationship between many sections. For example, there is a need to leverage and create standards which enable the development of new models of care.

2 HIMSS would like to comment on the role and importance of mobile technologies in the future delivery of healthcare in the United States. According to CTIA, approximately 320 million wireless subscriptions exist, which exceeds 101% of the United States population. 1 Furthermore, studies by the Pew Internet & American Life Project have found that usage of mobile devices stretches across culturally diverse populations, with 52% of smartphone users gathering health information on their phones; some 19% of smartphone owners have at least one health app on their phone. 2 Mobile health technologies and mhealth have the potential to dramatically alter the course of healthcare. mhealth will dramatically help inform and empower patients to take control of their own healthcare delivery and health information. A knowledgeable patient can make the dramatic lifestyle changes and healthcare choices that are absolutely necessary in controlling chronic disease, the largest driver of healthcare costs. The HIMSS Board of Directors approved Public Policy Principles clearly express the potential and the approach HIMSS recommends the Nation and the Congress take in regard to mobile health technologies. Our approach is reiterated below. Mobile Health. The following is extracted from the HIMSS Public Policy Principles, Section 13, Mobile Health (approved by the HIMSS Board of Directors on December 7, 2012): 13.1 Promote clinical and financial effectiveness, as well as efficiency associated with the use of mobile health technologies (mhealth) Integrate mobile technologies into the design and deployment of healthcare information technology systems to leverage current and future incentives associated with ONC s Meaningful Use definition and CMS s Incentive Payments regulations Support the use of mobile technologies through healthcare focused applications (apps), web portals, wireless platforms, and mobile devices to increase patient awareness and encourage engagement in their healthcare and interaction with providers Promote future strategies, applications, and reimbursement policies which encourage and incentivize the effective use of mobile technologies that will help reduce costs, among other benefits Monitor the regulatory environment for legislation and promulgation which affects mobile technology, mhealth, as well as the pace of innovation to ensure that innovation is not hindered, Susannah Fox, Maeve Duggan. Mobile health has found its market: smartphone owners, Pew Internet & American Life Project, Washington, D.C. (November 8, 2012). accessed March 13,

3 but rather encouraged Support the use of mhealth as an element of best practices, patient care, patient engagement, patient-centered outcomes research, and risk management in the implementation of new healthcare models Encourage and promote the coordination and simplification of mobile-focused standards of operation and data protocols by engaging with existing and emerging bodies governing the certification of mobile apps and other processes Support increased interoperability between mobile devices and anchored health systems, including cloud-based applications, while advancing the concept of application-to-application interchange of data and bi-directional responses Encourage collaboration with private sector innovators developing medical apps for use in mobile healthcare settings Support the safe, effective, and secure application of mobile and wireless technologies to advance population and public health Collaborate with stakeholders to work towards a unified regulatory approach in the field of mhealth. HIMSS recommends Congress encourage private sector mobile technology innovators including mobile platform suppliers and related medical application developers to make security controls (e.g., encryption software, data lockbox, etc.) universally available on mobile devices, and to put in place mechanisms to allow patients to understand the functionality and safeguards of mobile medical applications. Regulation of Health IT as Medical Devices HIMSS recommends that the federal Food and Drug Administration (FDA) not define medical device to include software or hardware if it is not integral to the functioning of a traditional diagnostic, therapeutic, or surgical device. For example, the definition of medical device should not cover software or hardware that provides clinical decision support, EHRs, simply transmits or allows other parties to read information originally sent from a medical device or technologies that are widely used in other industries. Congress should ensure that FDA does not regulate such software or hardware. Stark Exemptions and Anti-Kickback Safe Harbors for EHRs. Finally, HIMSS supports making permanent and expanding the Stark exemptions and antikickback safe harbors for EHRs to cover additional healthcare software and related devices. Congress should encourage the Secretary of Health and Human Services to implement necessary measures to protect against conflicts of interest and improper relationships among providers. 3

4 In summary, patients in the United States deserve access to safe and innovative technologies to enable the best possible healthcare delivery and affiliated outcomes. Furthermore, innovators and stakeholders require appropriate and predictable approaches to low risk applications in the healthcare market. By ensuring clarity of regulations through guidance in a technologically fast moving space FDA, in collaboration with other key mhealth stakeholders, will ensure that providers and patients will have assurance of the integrity of available mobile technologies and mhealth application. HIMSS appreciates the opportunity to comment on this important public policy topic for our members and health IT community colleagues. We look forward to continuing the dialogue between our members and the Committee to ensure the continued success of health information technology as a transformational force in the betterment of healthcare for all Americans. If you have any questions, please contact Richard M. Hodge, HIMSS Senior Director of Congressional Affairs, at Sincerely, Willa Fields, DNSc, RN, FHIMSS Chair, HIMSS Board of Directors Professor, School of Nursing, San Diego State University H. Stephen Lieber, CAE President/CEO HIMSS Enclosure: mhimss Roadmap cc: The Honorable Anna G. Eshoo, Ranking Member, Subcommittee on Communications and Technology,, The Honorable Fred Upton, Chairman, Committee on Energy and Commerce, United States House of Representatives, United States House of Representatives The Honorable Henry A. Waxman, Ranking Member, Committee on Energy and Commerce, United States House of Representatives, United States House of Representatives The Honorable Bob Latta, Vice Chairman, Subcommittee on Communications and Technology, The Honorable Edward J. Markey, Subcommittee on Communications and Technology, The Honorable John Shimkus, Subcommittee on Communications and Technology, Committee The Honorable Michael F. Doyle, Subcommittee on Communications and Technology, The Honorable Lee Terry, Subcommittee on Communications and Technology, Committee on The Honorable Doris O. Matsui, Subcommittee on Communications and Technology, The Honorable Mike Rogers, Subcommittee on Communications and Technology, Committee on 4

5 The Honorable Brue Braley, Subcommittee on Communications and Technology, Committee on The Honorable Marsha Blackburn, Subcommittee on Communications and Technology, The Honorable Peter Welch, Subcommittee on Communications and Technology, Committee on The Honorable Steve Scalise, Subcommittee on Communications and Technology, Committee The Honorable Ben Ray Lujan, Subcommittee on Communications and Technology, Committee The Honorable Leonard Lance, Subcommittee on Communications and Technology, Committee The Honorable John D. Dingell, Committee on Energy and Commerce, United States House of Representatives The Honorable Brett Guthrie, Subcommittee on Communications and Technology, Committee The Honorable Frank Pallone, Subcommittee on Communications and Technology, Committee The Honorable Cory Gardner, Subcommittee on Communications and Technology, Committee The Honorable Bobby L. Rush, Subcommittee on Communications and Technology, Committee The Honorable Mike Pompeo, Subcommittee on Communications and Technology, Committee The Honorable Diana DeGette, Subcommittee on Communications and Technology, Committee The Honorable Adam Kinzinger, Subcommittee on Communications and Technology, The Honorable Jim Matheson, Subcommittee on Communications and Technology, Committee The Honorable Billy Long, Subcommittee on Communications and Technology, Committee on The Honorable Renee Ellmers, Subcommittee on Communications and Technology, Committee The Honorable Joe Barton, Chair Emeritus, Subcommittee on Communications and Technology, 5