Clinical Studies Highlighted in HHS Task Force Recommendations for mHealth Text Messaging


     The Text4Health Task Force of the HHS made recommendations to the Secretary of HHS regarding text messaging for mHealth. (There is currently an evaluation of the text4baby program, a public-private partnership that is the first free-to-end-user health text messaging program available nationwide).

 It was a comprehensive document with recommendations regarding the following:

·         Facilitating Text Messaging Development

·         Research and Evaluation

·         Partnership Among Federal Government Agencies and with Non-Federal Organizations

·         Coordination Across HHS

·         Integration of Health Text Messaging/mHealth with Other HHS Health Information Technology Priorities (EHR, cloud computing, health games, etc).  The task for recommends that HHS align text messaging/mHealth activities with other HHS Health IT priorities.

·         Delineating Privacy/Security Issues.

·         Regulatory Issues: Establishing regulatory guidelines.

 

In the Recommendations regarding studies, the following is stated: “Future health text messaging programs by HHS, or in which HHS is a partner (not specified whether operational partner or reimbursement partner) should also include a scientific evaluation component.”  One of the guiding principles, “To Establish Plans for Evaluation and Implementation” is to ‘conduct formative usability and user-centered research with the target audience at the beginning of the project and when major program changes occur.”

The regulatory recommendation states that relevant HHS agencies including the FDA conduct research on future trends and establish regulatory guidelines for interactive systems.  These guidelines will no doubt include quality control regulations that will involve clinical testing of the technologies prior to and perhaps post-marketing, much like other medical devices.

The recommendation about integration of mHealth with other HHS HIT priorities has huge mHealth industry implications.  This is the recommendation that puts all of mHealth on the table, in the spotlight, and highlights government recognition of many other  aspects of mHealth technology besides text messaging.  In addition it stresses the importance of interoperability of these technologies with EHRs, blending the overall IT efforts of the ONC.

So clearly these set of recommendations are great news for mHealth.  They essentially signal the dawn of mHealth with regards to recognition as a useful medical tool.  They signal government’s commitment on a large scale to supporting the industry’s goals.  They signal the initiation of the patient management side bookend of the HITECH Act.  However, they also signal the expansion of regulatory aspects of mHealth.  Hopefully, as alluded to in recommendations to work with non-Federal organizations and private sector endeavors, they do not imply significant impediments to the research, development or marketing of worthy technology from either a technical or economic standpoint.  We all await the HHS’s adoption and implementation of these recommendations with hopefully public opinions raised before the final rules are decided.  The recommendations may be found at: http://www.hhs.gov/open/initiatives/mhealth/recommendations.html

 

About davidleescher

David Lee Scher, MD is Founder and Director at DLS HEALTHCARE CONSULTING, LLC, which specializes in advising digital health technology companies, their partners, investors, and clients. As a cardiac electrophysiologist and pioneer adopter of remote patient monitoring, he understood early on the challenges that the culture and landscape of healthcare present to the development and adoption of digital technologies. He is a well-respected thought leader in mobile and other digital health technologies. Scher lectures worldwide on relevant industry topics including the role of tech in Pharma, patient advocacy, standards for development and adoption, and impact on patients and healthcare systems from clinical, risk management, operational and marketing standpoints. He is a Clinical Associate Professor of Medicine at Penn State College of Medicine.
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