Wireless-Life Sciences Alliance asks government to update regulatory framework with an eye to the future

Posted on September 14, 2010

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As there becomes a more pronounce desire in us baby boomers to look  for lifestyle decisions that allow us to age in place (read ‘at home’), the more we will come to rely on new technology, specifically in the mobile and wireless space, to help keep costs down. This emerging area of health care is starting to attract government oversight and regulatory involvement. That may not be all bad, however, one should take a look at when current regulations were written and the difference in that time and the present. Here is how the WLSA is putting forth their member thoughts to the FCC and the FDA as to considerations that should be weighed in this developing technological framework.

LA JOLLA, Calif., Sept. 8 – /PRNewswire/ — As wireless technologies become faster and cheaper, they create additional opportunities to improve patient care and reduce health care costs for every American. In a recent filing with the Federal Communications Commission (FCC) and the Food and Drug Administration (FDA), the Wireless-Life Sciences Alliance (WLSA) makes four sets of policy recommendations for federal agencies as they craft guidelines and regulations for wireless health technologies.

Wireless health technologies benefit patients by delivering efficient “telemedicine,” such as remote patient monitoring systems that automatically alert a physician when readings fall outside a predetermined range. Besides potentially saving the patient’s life, such systems also reduce health care costs. For example, private and public insurers can justify the expense of wireless glucose-monitoring systems for diabetics because they help to significantly reduce the risk of long-term complications such as amputation, blindness or heart disease.

But these solutions are only the beginning. Tomorrow’s advances in wireless life sciences depend partly on the federal government creating a regulatory framework that provides medical device manufacturers, physicians, insurance companies, wireless carriers and other ecosystem members with guidance and clarity in three key areas: cost, quality and access.

To assist the FCC and FDA in developing that framework, the WLSA filed comments on August 16 that include four recommendations:

  • When determining whether to permit a new device to be marketed, regulators should consider the status quo risks of not allowing it. An example is the risk that private insurance, Medicare or Medicaid will continue to bear the high cost of avoidable readmissions – funds that otherwise could be used to help more patients.
  • Regulators should consider the use case and marketing claims prior to approval decisions and standards setting, This process includes taking into account such factors as place of use, acuity of services, availability of back-up services (including self-help) and status quo risks. An example is comparing the needs of an “aging-in-place” service (where gaps in connectivity can be managed) and a wireless ICU monitor (where connectivity must be substantially “perfect.”
  • Regulators also should establish quality-of-service expectations, to be managed by marketing claims, rather than defining how they must be achieved. This approach ensures that healthcare will benefit from the benefits of volume that have so rapidly improved the consumer electronics and mobile services markets. The quality of products and services will rapidly improve over time if technical standards are not frozen in regulation.
  • Wherever possible, regulators should use post-market surveillance and reporting to manage the risks associated with new technologies. 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 these inherent capabilities to accelerate the marketing of useful devices and services while monitoring their performance compared with marketing claims.

“The WLSA applauds the FCC’s and FDA’s initiatives to encourage ‘fast innovation’ in wireless life sciences by creating much-needed regulatory clarity for this rapidly growing industry,” said Robert B. McCray, WLSA President and Chief Executive Officer. “By taking this leadership role immediately, the FCC and FDA are helping extend more comprehensive, more affordable and more convenient care to Americans, including those living in historically underserved areas such as rural communities. The WLSA stands ready to assist the FCC, FDA and any other government agency as they help pioneer an industry that’s capable of helping every American everywhere.”

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