All posts by Thy-Ann Nguyen

Thoughts on Politico’s ‘Health Care of the Future’

At a recent event sponsored by Politico and Microsoft, an interesting mix of innovators and policymakers gathered to discuss how modern health technologies, such as mobile apps and clinical support tools, are changing the future of health care as well as the role that policy plays – or should play –  in the advancement of such technologies.

The impressive list of participants in this informative discussion included Dr. Farzad Mostashari, National Coordinator for Health IT for the Department of Health and Human Services (HHS), Christy Foreman, Director of the Food and Drug Administration’s (FDA) Office of Device Evaluation, Dr. Joe Smith, FACC, Chief Medical and Science Officer of West Health, Dr. Jordan Shlain, Founder of HealthLoop, among others.

As an attendee of the event, I came away with the following key themes and issues:

–          There is a gap between health policy and health care technology innovation.

Although the FDA has developed rigorous testing to determine the safety and efficacy of medical devices and drugs, they have yet to establish standards for recent health care innovations such as mobile health apps. This poses a problem as there are thousands of apps used for health care purposes every day. According to Joel White, executive director of the Health IT Now Coalition, “technology is changing in such a rapid innovative pace, and the current [regulatory] structure doesn’t work.”  There seemed to be a consensus among the non-policymaking participants of the panel on White’s statement. Dr. Joe Smith stated that “the government is struggling at the moment, we’ve witnessed a technological impact in every other aspect of our lives, and healthcare has escaped from it.”

 In the defense of policymakers, Farzad Mostashari states that regulations are much more enablers of innovation than health care technology developers think, the issue is that “[developers] don’t understand the regulations and rules.”

Although steps have been taken by the government to develop standards on mobile health technology, such as draft guidance on mobile medical applications that FDA released in 2011, clear standards need to be defined in order for health care innovation to reach its full potential. One thing we can certainly look forward to is FDA’s final mobile medical app guidelines, which Christy Foreman said will be available by October of this year.

–          With the quantity of data and health care technology out there – developers must not lose focus on quality.  

According to Audie Atienza Ph.D., senior program director of the Science of Research and Technology Branch of the National Cancer Institute, there are currently between 20,000 to 40,000 apps that are used for health, wellness or fitness purposes. With this number of apps, how are they being tested for effectiveness and reliability? The simple answer is that they’re not. While the FDA has developed draft mobile medical guidelines, it has become the health technology developer’s prerogative to ensure that they’re not innovating for innovation’s sake – technology must be meaningful and centered on the patient to make a lasting difference.

Atienza provided one example of how using technology in the right way can lead to desired results – when the National Institute of Health (NIH) sought to reduce teenage smoking, they launched a campaign centered on text messaging called SmokefreeTXT. NIH found that a sizeable percentage of teens using the service were quitting smoking after using their text-messaging service over a length of time. Health technology developers should take a page from NIH’s book – the key to successful innovation is to make it meaningful to its users.

–          There needs to be a shift from the current reactive nature of our health care system to a proactive one.

Dr. Jordan Shlain used a great term to describe our current health care system, calling it a “reactive health care system”. I couldn’t agree more; our health care system focuses on treating patients’ illnesses, rather than providing patients with tools that help them to avoid illness in the first place. Although the health care reform law attempts to address this issue by punishing hospitals that have excessive hospital readmissions, Atienza took it one step further and says that we need to prevent admissions, not just readmissions.

What’s Dr. Shlain’s solution to making our health care system a more proactive one? Email.   He states that personal medical records (PMRs)/electronic medical records (EMRs)/electronic health records (EHRs) capture a fraction of a patient’s health history, but “we live 99 percent outside of the EHR.”  He believes that creating a system that allows doctors to regularly engage with patients by email will keep patients out of the hospital.  Although there are many obstacles to making email a widely adopted practice by doctors, such as fear of malpractice and privacy concerns, I believe that more people need to be thinking like Dr. Shlain. In order for the health care system to be proactive, its players – doctors and patients – need to be proactive.

We’re in an era in which innovations in health care are growing at an ever-increasing rate, but this seemingly boundless potential of health care technology brings its own set of problems. The key is to find the balance between advancement and the quality of the technology. The leaders that participated in this panel brought these issues to table, but there needs to be a systemic discussion among all leaders in the industry in order for health care technology to reach its full potential. This event may be one baby step, but as health care communicators we are uniquely situated to encourage our clients and colleagues to promote and advance key health care issues of our day – one thing I hope you take away from this is to encourage your clients to promote meaningful health care innovation.


“FDA Communications Oversight in a Digital Era”—our conversation with Eye on FDA’s Mark Senak

MarkSenakBioPicMark Senak,  lawyer and partner at international  PR firm Fleishman-Hillard and founder of Eye on FDA blog, recently published a white paper on the FDA’s oversight of digital and traditional communications in the pharmaceutical industry.  Mark’s white paper discusses how the FDA and its Office of Prescription Drug Promotion (OPDP) have been monitoring both digital and traditional forms of communication to ensure truthfulness and validity in this public form of communication.

This week Mark took the time to catch up with us for a brief Q&A on his paper – here’s what he had to say:

Health Care Policy Matters (HCPM): How did you become involved in FDA regulation of pharmaceutical communications and what made you decide to start building this data base of FDA/OPDP Warning letters?

Mark Senak:  During the 1980s and 1990s, I worked in advocacy at the two largest AIDS/HIV service organizations in the country.  AIDS activism was really responsible for breaking the health care advocacy mold and recasting it in its own image.  A big part of the movement was a real look at how new drugs were considered and approved in this country.

My interest in that process has never gone away and when I joined a communications firm in 1997, since I am a lawyer by training, the regulatory aspect of communications seemed a good fit.

HCPM: What exactly are FDA/OPDP Warning and NOV letters, and when are they issued?

Mark:    There is more than one outlet for Warning Letters at FDA, but the ones that express the agency’s regulation of promotional communications by pharmaceutical companies come from OPDP – and are not produced on a schedule, but rather in response to a perceived violation.  They put a company on notice that a particular means of promotional communication may have been out of bounds from a regulatory perspective.

HCPM:  Why did you choose to compare digital vs. non-digital communication regulation by the FDA as your first analysis of the database?

Mark:    First of all, I built the database as a means of providing us [FH] with evidence-based answers to common questions people have – Has FDA issued a letter over a press release?  Are there special considerations for video?

FDA has been struggling for years regarding the regulation of the Internet and social media, but has never produced any comprehensive guidance.  The fact that there has been so little policy regarding digital media contrasts sharply with the fact that health-related research and information seeking is a primary and growing use of the Internet. Additionally, in the past few years, social media has fundamentally changed communications, so an examination of enforcement patterns regarding digital made a lot of sense.

HCPM: Do you think that manufacturers and those in the health care industry should limit their posting on social media/digital platforms? Or should they take advantage of this ever growing exchange of information?

Mark:    The regulatory culture of every organization is different.  There is risk associated with any communication – whether a traditional media platform or a digital one.  In one respect, the medium doesn’t matter – if your message is in violation, you’re in violation.

That said, one thing that did come up in looking at the data base is that some communications platforms have their own risks.  For example, videos with patient testimonials tend to have more violations regarding a broadening of indication or unsubstantiated claim because people tend to talk in real terms about the difference a treatment made in their lives – which may not be on the label.

Sometimes it is not the message, but the medium.  There are definitely unanswered regulatory questions about digital media and there are issues that pertain solely to digital and not traditional media.  As to whether or not digital is a way to go for a company, it is going to depend on their appetite for risk in that kind of environment.  A lot of companies have gotten very involved in digital media in general and social media in particular.

HCPM:  In your opinion, what are the biggest challenges for the FDA in regulating digital and social media communications by pharma companies?

Mark:    There are a LOT of them.  Consider the fact that we have a medium (1) which provides a permanent record (usually), (2) where the audience can participate, comment and change content, and (3) keeps morphing where platforms come and go.

Change the strategic equation and you have a whopping big problem in terms of guidance for the use of it.  All three of these things take the communications environment off the printed word and broadcast and add a bunch of new dimensions.  In addition, the agency has a very slow way to address external change, while at the same time external change is happening at a fast pace.

HCPM: If you were in a position in the FDA to create ways to monitor digital and traditional communications of pharma companies, what methods would you propose to promote transparent, truthful communications?

Mark:    That could be the subject of an entire conference.  But a few things that I would do to change the status quo is:

  1. Prioritize enforcement in areas where there is a real public health issue as a result of communication, not just where there is a technical violation; and
  2. I would set up an advisory committee process to help the agency assess the changing environment and its implications more quickly, decide what the strategic priorities should be and to help suggest new policies to meet emerging challenges and better communicate new regulatory parameters.

HCPM: Do you believe the FDA should have a “digital seal of approval” that would appear on social media websites? An example of that would be the blue verified badge that appears on twitter profiles that have been verified as authentic identities.

Mark:    The whole difference between digital and traditional content is that digital is participatory – meaning that the audience now is part of the equation and can change and alter the content.  It would really be difficult to keep up with a constantly changing site and give it a seal of approval.  If it’s not a constantly changing venue, then it is a brochure – it may be digital – but it is static.

HCPM:  Are you planning any future analyses or reports based on the information in the database?

Mark:    Yes, over time I will be exploring various questions of the data and writing about them on Eye on FDA.


The FCC’ s road to mHealth adoption


In May 2012, the Federal Communications Commission (FCC) passed an unprecedented ruling that made the United States the first country in the world to dedicate a specific spectrum of bandwidth to medical body area networks (MBANs), paving the way for increased innovation in wireless health devices.

MBAN technology consists of small, disposable sensors that capture real-time clinical information, such as body temperature and respiratory function, and send the data wirelessly to the nurses’ central monitoring station. MBANs free patients from the wires that would normally tether them to the hospital bed and allow clinicians to monitor patients wherever they are. With a dedicated wireless bandwidth spectrum for secure transmission of data from the patient to the clinician, medical device companies now have more flexibility to develop reliable, innovative wireless medical devices.

[Here is a video developed by Philips Healthcare that provides a succinct explanation of MBANs.]

This wasn’t the FCC’s first step in advancing wireless health care, or “mHealth.” In 2010, it released the “National Broadband Plan,” which laid out a strategy to expand the use of health IT solutions in hospital systems. But the MBAN ruling did signify a major push by the FCC towards universal mHealth adoption.

Shortly after the ruling, FCC Chairman Julian Genachowski held a summit with leaders in wireless health technology to discuss the obstacles and opportunities facing the adoption of mHealth in the U.S. The result of this summit was the creation of the mHealth Task Force. This “task force”, which consists of industry, academic and government members, was formed to draft a recommendations report for the FCC and other agencies to accelerate the adoption of mHealth in the United States.

The mHealth Task Force released the final report in September at an event hosted by the Information Technology and Innovation Foundation (ITIF). The main goal listed in the report was that “by 2017 mHealth, wireless health and e‐Care solutions will be routinely available as part of best practices for medical care”.

The recommendations outlined in the report were organized under five supporting goals:

  • Goal 1: FCC should continue to play a leadership role in advancing mobile health adoption.
  • Goal 2: Federal agencies should increase collaboration to promote innovation, protect patient safety, and avoid regulatory duplication.
  • Goal 3: The FCC should build on existing programs and link programs when possible to expand broadband access for healthcare.
  • Goal 4: The FCC should continue efforts to increase capacity, reliability, interoperability, and RF safety of mHealth technologies.
  • Goal 5: Industry should support continued investment, innovation, and job creation in the growing mobile health sector.

Out of the 25 recommendations made in the report, Chairman Genachowski stated that the FCC will act on the following:

  • Wireless health test beds: The FCC will propose an order by the end of the year to streamline experimental licensing rules to promote and encourage the creation of wireless health “test beds” to permit easier testing of mHealth technologies.
  • Health care broadband networks: The FCC will propose an order by the end of the year to comprehensively reform and modernize the Rural Health Care Program, to allow networks of hospitals and health care facilities to jointly apply for program funds, to boost broadband capacity, enable electronic health records and improve data collection.
  • International MBAN spectrum: The FCC’s International Bureau will work with FCC counterparts in other countries to encourage them to make spectrum available for MBANs and to discuss possible spectrum harmonization efforts to allow for medically safe cross-border patient travel and better economies of scale for device makers.
  • Outreach plan: The FCC will develop and execute a health care stakeholder outreach plan to promote further collaboration between the FCC and the health care sector.
  • Health Care Director: The FCC will recruit a permanent FCC Health Care Director, a position that functions as the central point of contact to external groups on all health-related issues.

Wondering what progress the FCC has made on these recommendations? So were we, so we took a look. Below are the FCC’s related accomplishments in the past four months:

  • Healthcare Connect Fund:  As proposed, the FCC reformed and modernized the Rural Health Care Program by creating the Healthcare Connect Fund. This new fund provides financial support to eligible health care providers (HCPs) for broadband services used for health care purposes and establishes a new pilot program to test ways of supporting broadband connections for skilled nursing facilities.
  • FCC launched a new health care-dedicated website: The FCC created, for the first time enabling people to find information on all of the FCC’s health care-related work in one place.
  • Health Care Director job posting: The FCC posted a new position for a Director of Health Care Initiatives. The job description states the role of this person would be to “lead the agency’s efforts in facilitating and promoting communications technologies and services that improve the quality of health care for all citizens and help reduce health care costs; facilitating the availability of medical devices that use spectrum; and ensuring hospitals and other health care facilities have required connectivity.” The posting expired on January 7, 2013 and no Health Care Director has been named as of yet.

The FCC has taken several important steps in implementing the task force’s recommendations, but there’s still a long way to go to reach the task force’s goal of making mHealth technology routinely available as part of  medical best practices in 2017. We believe that mHealth is vital to improving the efficiency and quality of health care and are rooting for widespread mHealth adoption. We’ll be watching the FCC’s progress closely and will continue to keep you updated.


Image source: