Complexities and Challenges in Developing mHealth Programs
By Audie Atienza, PhD, Senior Health Technology Advisor, HHS
Last month, we blogged about “Three Approaches to mHealth”. It is important to note that mHealth extends beyond mobile phones to other portable technologies (sensors, GPS, physiologic monitors, etc.). This blog addresses common complexities and challenges that HHS agencies/divisions may face in developing programs using various mobile technologies, and points to resources to help staff better understand key issues. There are many agencies and divisions (AHRQ, CMS, HRSA, NIH, etc.) under the HHS umbrella, and while each agency has unique issues, there are also common complexities and challenges across the agencies.
Common issues include:
- A need to create evidence-based, verifiable, evaluations of the programs.
- A need to address the longer-term sustainability of the programs.
- A need to address regulatory and privacy/security issues.
Evaluation: A rigorous evaluation is critical to modifying and improving mHealth efforts at the HHS. You don’t know what works unless you measure it! Complexities arise when mHealth programs have inherent limitations on the types of data that can be readily collected. For example, a mobile-friendly website can collect traditional website statistics to determine reach, but other non-web-based mHealth programs (e.g., Office of Minority Health's Diabetes Self Management Training program using smart phone video conferencing) may not have this built-in data collection capability, and require an independent evaluation to determine reach. Furthermore, determining whether a program changes behavioral or health outcomes often requires additional evaluation resources/funds, as well as, IRB or OMB approval. The approval processes can be time-consuming and complex, so learning from others who have successfully navigated the processes is highly recommended!
Sustainability: Although not unique to HHS, sustainability of mHealth programs also represents a complex and challenging issue. At HHS, sustainability issues touch on funding (e.g., appropriations), partnerships and related policy (e.g., mission and priorities) issues. While there is not a single solution to manage these complexities, HHS program leads should outline potential avenues for sustainability during the initial phases of program development.
Regulatory and Privacy/Security Issues: Whether developing mHealth tools within HHS or collaboration with outside partners, regulatory and privacy/security issues need to be addressed. Complexities and challenges arise because several rules and regulations relevant to mHealth are under development or being updated. For patient-related mHealth programs, the FDA’s guidance on mobile health applications is being developed and the HIPAA privacy rule is being updated. Of particular relevance to federal programs, Section 508 of the Rehabilitation Act is being revised. In addition to HIPAA considerations for patient-related programs, consumer-based mHealth programs must adhere to rules that are the purview of the Federal Trade Commission. Knowing the rules and keeping track of updates is a must!
As HHS mHealth programs and partnerships proliferate, these 3 common challenges require attention and thoughtful deliberation. In the end, attending to these common issues will help mHealth programs meet the HHS mission of improving public health.