What's Been Happening in mHealth: Update
Since my last blog post here at Medical Connectivity there have been some mHealth updates that may be of interest to the blog readers.
USA and FCC
Just this week the FCC released its task force findings on mHealth. The overarching goal given to the task force was: “By 2017 mHealth, wireless health and e-Care solutions will be routinely available as part of best practices for medical care.” They were to produce actionable recommendations that could be taken by the FCC, other regulatory agencies and industry to reach this goal. The FCC committed to implementing five specific actions in the list produced by the task force:
a) Immediately recruit for an FCC Medical Director position
b) Develop and execute a health care stakeholder outreach plan to promote greater collaboration between the FCC and the health care sector on policies at the intersection of communications and health.
c) Direct the International Bureau to work with FCC counterparts in other countries to encourage them to make spectrum available for MBANs and to discuss possible spectrum harmonization to allow for medically safe cross-border patient travel and better economies of scale for device makers.
d) Consider an Order by the end of this year to comprehensively reform and modernize the Rural Health Care Program, and
e) Consider an Order by the end of this year to streamline our experimental licensing rules to promote and encourage the creation of wireless health “test beds” to permit easier testing of mHealth devices.
More information regarding the findings can be found here.
So in addition to the FDA and FTC, the FCC is signaling a significant re-direction and involvement in the mHealth industry. What does this mean to those in the healthcare industry? One would hope that the patchwork of regulations that cover this gray are become more integrated and clear for those who wish to delve into this part of the healthcare industry. In the case of the USA, this does signal that the FCC understands that access to a communications infrastructure is a requirement to increase access to healthcare and other industries in remote areas. Moreover, the FCC recognizes that the healthcare industry is large enough and relies and will continually rely more upon the telecommunications infrastructure to be viable. Lastly, the FCC Chairman stated that another goal is for the USA to be the country were mHealth is the standard and sets the standard for the world.
Certification of Mobile Medical Applications
In the mobile medical applications realm, there is an organization that is working to make evaluating, purchasing and possibly developing Mobile Medical Apps easier: Happtique. According to the FAQs, Happtique is “mobile application store developed by healthcare professionals for healthcare professionals. Happtique offers healthcare enterprises—like hospitals, continuing care facilities, and physician practices—the ability to create individually branded, secure substores that support employee and patient mobile technology use.”
What is novel about this particular organization is that in order to be able to market an application on Happtique, the vendor must certify (and Happtique will verify) that they meet specific standards as per the Happtique guidelines. These guidelines range from networkability, to protection of privacy to use of medical interoperability data standards.
To get an idea of what mHealth applications are currently available throughout the world, GSMA offers a mHealth tracker on their website which had listed the day this was written 707 mHealth products and services available around the world. Not all of these are certified by Happtique, but perhaps in the future, the list of applications on these two website will converge.
Danish Telemedicine Action Plan based on Continua Guidelines
In news from across the pond, the government of Denmark has decided that their National Telemedicine Action Plan will be built on Continua Health Alliance Design Guidelines for personal connected health devices. What is interesting about this is Denmark happens to be one of the countries in Europe who has adopted data and other interface standards for healthcare for over 20 years. In fact, their current ‘medical device interface data’ standard is based on Electronic Data Interchange (EDI). They will need to somehow work on a harmonization or convergence of HL7 and EDI for this effort to be effective; however, it should be interesting to see this progress. HL7 and EDI are messaging standards, so using the underlying data standards in the Continua Design Guidelines will definitely bring even more stringency in their standards-based approach. The Danish Medcom site is a great website to see their 20 year progress on Health IT and interoperability and highlights the information in English.
Tim Gee is Principal and founder of Medical Connectivity Consulting (MCC) (www.medicalconnectivity.com). Tim’s practice revolves around workflow automation through the integration of medical devices with information systems, and enabling technologies. MCC advises healthcare providers and manufacturers on needs assessment, requirements, workflow and patient flow analysis, regulatory issues, ...