As broadband Internet connections in the home and wireless mobile accessibility provided by mobile devices extends the reach of healthcare providers beyond the four walls of their offices. Telecommunication companies will play an integral role in the future of healthcare. The shift toward in-home patient care and monitoring, or via mobile communications as patients go about normal daily activities, represents a significant opportunity for telecommunications companies to shape a new healthcare delivery model that de-emphasizes reactionary intermittent acute-care encounters and emphasizes continuous predictive care and wellness management.
Beyond basic connectivity, major telecommunications companies are developing value-added services for healthcare information exchange, remote patient monitoring, and high performance cloud computing data analysis and storage services.
The move into higher levels of services with more direct patient care creates new potential regulatory considerations for an industry that has traditionally been intimately involved with the type of data traversing its communications infrastructure. FDA regulatory guidance for medical technology beyond a well-contained closed-loop system has been relatively limited, with some guidance for close-proximity wireless connectivity to PC-based medical devices, or for communications from devices connected to voice-grade telephone service (“plain old telephone service” or POTS) through copper lines, a technology that is rapidly diminishing as the prevailing means for connectivity.
Today’s modern, complex, and rapidly evolving telecommunications infrastructure bears little resemblance to the circuit-switched model of the past. Broadband Internet access, VOIP, 3G/4G mobile networks, smart mobile and wireless devices, and fixed mobile convergence services that utilize a variety of competing technologies will be increasingly utilized to enable mobile patient diagnosis, treatment, and monitoring. The rapid ascent of smart phone and tablet computer technologies that easily switch between mobile and wireless networks to provide an “always on” user experience, coupled with the burgeoning number of “machine-to-machine” devices connected over the same networks, brings new opportunities and risks to what is possible in mobile healthcare.
Lack of Familiarity with FDA is the biggest challenge
While telecommunications companies are no strangers to government regulatory oversight, they lack familiarity and direct experience with medical technology regulations. Regardless of whether a telecommunications company’s products may be considered medical devices, the company’s knowledge of the regulations applying to medical devices connected to its networks will be important for overall risk assessment and mitigation. The Anson Group can assist telecommunications companies entering the medical technology space.
Anson supports:
- Development of regulatory compliance strategies
- Evaluation of potential telecommunications partners who are regulated for compliance as medical device manufacturers
- Assessment of roles and responsibilities for suppliers of regulated medical device manufacturers
- Assessment of intended-use claims for telecommunications companies
- Educational training on the requirements of FDA regulations that apply to medical technologies
