Comments of the Wireless-Life Sciences Alliance with respect to the FCC/FDA Joint Meeting on Life Saving Wireless Medical Technology
Docket # FDA-2010-N-0291
The Wireless-Life Sciences Alliance (WLSA) is a special purpose nonprofit trade organization for innovators, globally relevant companies, scientists, physicians, and policy makers. We were founded in 2005 and are dedicated to creating value and improving health, globally, through the convergence of communications technologies, consumers, caregivers and all sectors of the life sciences and technology environment. WLSA partners and companies all over the world are using wireless health innovations to better manage chronic conditions, preempt disease and improve the lives of the elderly and under-served populations around the world. It is the WLSA mission to accelerate these developments.
We believe that WLSA was the first organization of its type to focus exclusively on the opportunities presented by utilizing wireless technology to lower the costs and improve the quality of healthcare services and to improve the quality of life for millions of Americans and billions of people around the world. Since 2006, we have been convening the best companies, innovators and thought leaders in this emerging space. Of the 21 companies demonstrating their products at the Joint Meeting, 17 were members of participants in our meetings. Five of the panelists at the hearing represented member companies. Our CEO and our Chairman have been exploring and writing about the opportunities and challenges of wireless health since early in this decade.
The WLSA supports the initiative of the FCC and FDA in joining together to work in this most important area. The Joint Statement issued on July 26th establishes an excellent framework for the agencies’ efforts. We applaud paragraph number 5 for its vision of the future:
“5. The FDA and the FCC agree to build upon this initiative launched today to proactively serve the national interest in finding innovative solutions to America’s health care challenges.”
We emphasize that in wireless health we have the potential to address three of the most important issues in healthcare:
- Its high cost.
- Variability in quality.
- Inadequate access.
The power of wireless health from a public policy perspective derives from its power to bring accountability to the opaque healthcare industry.
- Wirelessly enabled solutions for consumers/patients make them more accountable for their health (reference the importance of lifestyle in creating chronic disease and the importance of compliance to managing chronic disease).
- Wirelessly enable healthcare services for providers makes them more accountable for outcomes (reference CMS hospital readmission policy and the need for wearable vital signs monitors to implement it in a cost-effective way).
- Wireless connectivity for medical devices makes manufacturers more accountable for device functionality (reference Guidant recall of more than 100,000 defective implanted defibrillators – wireless monitoring could have identified the defects earlier).
While we do not now offer technical comments on the many topics in wireless health, we offer the following principles for your consideration.
- First Principle: In determining whether to permit a new device to be marketed, consider the status quo riskof NOT permitting the use of a wireless health device as measured by such considerations as:
- The interests of people who could be helped (e.g. frail elderly able to remain independent of an institutional sentence).
- The systemic benefits of expanding access to care by reallocating federal resources, such as savings from not paying for avoidable readmissions, toward coverage of the uninsured.
- Second Principle: Consider the use case and marketing claims prior to approval decisions and standards setting, taking into account such factors as place of use, acuity of services, availability of back-up services (including self-help) and considering the first principle. We note that some discussions during the hearing jumbled up use cases that require vastly different demands for quality of service. For example, compare the needs of an “aging-in-place” service and a wireless ICU monitor. Referencing the first principle, also compare the status quo – if the wireless platform enables the monitoring of a previously unmonitored situation, the expectations for quality of service should be dampened.
- Third Principle: Focus on establishing quality of service expectations, to be managed by marketing claims, rather than defining how they must be achieved. We do not want to freeze innovation and it is demonstrable with consumer electronics and mobile services that the quality of products and services will rapidly improve over time if technical standards are not frozen in regulation.
- Fourth Principle: Use post-market surveillance and reporting as a mechanism to manage the risks associated with new technology. Cell phone-based and wearable wireless monitoring platforms offer the ability to monitor and report on the use of devices and the efficacy and side effects of therapeutic products and services. The agencies should take advantage of this inherent capability to accelerate the marketing of useful devices and services while monitoring their performance compared with marketing claims. This approach will help the healthcare industry to adopt the high tech approach of getting “fast innovation” to continuously improve technology.
In conclusion, we reiterate our support for the constructive approach adopted by the agencies and pledge our support. The U.S. is a global leader in the life sciences and it can retain its role as the global leader in wireless health with the support of the agencies. Wireless health has significant policy benefits for the U.S. and the entire world:
- Improve access to services.
- Lower the cost of healthcare.
- Improve the quality of healthcare.
- Make healthcare services transparent and thus measurable and accountable.
- Improve health!
Robert B. McCray
President & CEO, Wireless-Life Sciences Alliance