For those that hadn’t heard, the FCC’s mHealth Task Force issued a report last week about the state of mobile health and recommendations for the future. I hope I’m not alone in being slightly overwhelmed by all the various parties regulating, assessing, and providing guidance on the mobile health industry. I understand why the FDA, FCC, HHS, mHIMSS, Happtique, WLSA, and several others are contributing to or facilitating the discussion, but it’s increasingly seeming like a disjointed effort. This has nothing to do with the FCC or its report.
The FCC report focused on e-care technologies and was inclusive of mHealth, but not limited to it. With that in mind, I was encouraged to discover the main goal of the report – that by 2017 connected health technologies will be "routinely" available in best-practice medical care. I think five years is an aggressive timeline, but you might as well shoot for something, and the wording is probably vague enough that we’ll hit it one way or another.
Five years is a long time, but we have a ways to go to scale mobile health. We aren’t doing some of the things we need to do around consumer / patient and provider awareness.
The big thing everybody talks about with mHealth are the barriers to adoption. The biggest barriers to me are reimbursement, knowledge and understanding of mobile health tools by providers and patients, and integration into clinical workflow. I heard Joseph Kvedar say last week that reimbursement and clinical workflow are closely related.
The barriers found by the task force, which are supposed to be addressed in the recommendations of the report, are below. Overall I think these are probably too complicated, and unnecessarily burdensome in the near term. Or maybe I tend to look at immediate barriers more than things that block step 4 or 5 in a process.
- Lack of access to fixed and mobile broadband coverage for providers and patients, particularly in rural areas. I guess this is true and particularly important in if real-time connected services are being evaluated.
- Future bandwidth constraints brought on by increased overall usage as well as data intensive medical applications. I’ll defer on this.
- Patient safety, privacy, and interoperability issues between healthcare solutions. This is the first part of the workflow problem. Tools need to be interoperable and integrate with existing systems, and then how they are used needs to be worked out.
- Reimbursement regulations and policies that do not incentivize the adoption of mHealth solutions. Yes.
- The broadband adoption gap for both fixed and mobile broadband services. Is this really a barrier to adoption? I’m not sure what the use case is for this. I realize bandwidth is an enabler, but I’m not sure this is preventing adoption.
- The absence of secure messaging between health information systems. OK.
The report breaks down the recommendation across five goals, listed below. I broke out each goal, but not in near the detail that the report did.
Goal 1: FCC should continue to play a leadership role in advancing mobile health adoption.
This is probably my favorite of the five goals. If I was writing a list of recommendations, I’d put a leadership role for myself first, too. In all seriousness, my bet is that the FCC has a role to play, but practically speaking, what role is that? I see the FDA regulating apps like mobile decision support tools, but what does the FCC bring? I’m fairly naive about the agency, so I Googled "what does the FCC do." The first link to the FCC website was not as helpful as the second link to Wikipedia.
Based on my basic research, here’s my impression of the role the FCC can play:
- Dedicate and manage spectrum specifically for health devices.
- Work to assure bandwidth is available for emergency services (healthcare services are implied in this bucket).
From the report, the main recommendation in this area that resonated for me was educating healthcare organizations, though the specifics of this recommendations were not entirely clear. Informing providers of available services, technologies, and regulations is much needed.
Goal 2: Federal agencies should increase collaboration to promote innovation, protect patient safety, and avoid regulatory duplication.
I agree that the FCC, HHS/CMS/ONC, and FDA should work together to assure efforts aren’t being duplicated and assess if the FCC may be able to help with broadband expansion to meet specific goals for CMS program changes. My fear is bigger committees = slower pace of getting things done.
The biggest recommendation in this area is that the FCC and all other relevant agencies (FDA, HHS, NIH, etc) should agree on a common terminology. Every mobile health or connected health meeting I attend and report I read starts with a definition of purpose or mission, and then something to the effect of "it doesn’t matter what terms you use" (mobile health, connected health, e-care).
The FCC also wants to have input into secure exchange of healthcare data, using the Direct Project as the example for this. Secure exchange is important, but I’m not sure where it fits within the six goals of the FCC.
Goal 3: The FCC should build on existing programs and link programs when possible in order to expand broadband access for healthcare.
This is an area I think the FCC can and should have real impact with mobile / connected health or e-care. The report talks about the FCC’s Rural Healthcare Program and Lifeline programs. Extending and expanding fixed and mobile broadband to rural and underserved areas is powerful generally, not just for health technologies. Connectivity is the starting point and has the power in health to create access where before it didn’t exist. Again, I’m still not sure this is what is preventing docs and patients from using mobile health technologies today.
Goal 4: The FCC should continue efforts to increase capacity, reliability, interoperability, and RF safety of mHealth technologies.
Expanding dedicated spectrum for healthcare is great. At a high level (and with almost no understanding of the negatives), I love the idea of health devices and certain communications having their own spectrum. I’m not sure it’s necessary, but theoretically it seems to be a positive thing for reliability and security, right? Or maybe it’s the opposite effect because the dedicated medical spectrum will not get the resources of the larger broadband spectrums.
With connected medical services (mobile and otherwise), the devices and data have the potential to demand huge amounts of broadband. One of the big areas is medical imaging, which also consumes tons of storage space. The FCC wants to work with medical associations to assure reliability of connectivity for transfer of medical imaging. I’d think the market would take care of most of this and just charge more for those transmitting large amounts of data, like imaging. But maybe the FCC’s role is to continually assess availability and work to meet growing needs. This at least seems clearly within the FCC’s charter.
Goal 5: Industry should support continued investment, innovation, and job creation in the growing mobile health sector.
As far as I can tell, this goal and recommendations won’t be a problem, at least for the foreseeable future. The industry will continue to build new services and hopefully some standards will emerge. As more money is pumped into healthcare from both private and public funders, more jobs will be created in the industry and human capabilities will increase.
I was more excited about this report and post before I started it. I hope it allows readers to avoid reading the actual report, but still sound knowledgeable about it if it comes up in discussion or in a meeting.