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The Food and Drug Administration (FDA) has proposed guidelines for a small number of health-related smartphone apps the agency could oversee. The concern: medical apps that could present a risk to patients if they don’t work as intended. The FDA is proposing to regulate “medical apps,” including those that function like medical devices that diagnose, treat, cure or prevent disease. An example might be an app that turns a smartphone into an electrocardiography (ECG) machine to find out if a patient is experiencing a heart attack.
NewPublicHealth spoke with Joseph Kvedar, M.D, director of the Center for Connected Health in Boston about oversight of medical smartphone apps by the FDA.
NewPublicHealth: Are these proposed guidelines a good idea?
Dr. Kvedar: In many ways, this is good news because I think there has been a bit of a chill in the mobile health industry for some time now because people were unsure what the FDA would regulate. And a number of companies didn’t add innovations because they were worried that the mobile phone itself might become a focus for FDA regulation. So their proposal is that they will be regulating certain uses of mobile technology in healthcare. This is not a bad place to start. It’s an advisory looking for commentary, so we have the option and the opportunity to give them some of our feedback on this.
NPH: What do you think should be the guidelines for determining regulating vs. not regulating a type of app?
A new report from the Institute of Medicine recommends eight preventive health services for women that health plans should cover at no cost to patients under the Patient Protection and Affordable Care Act. The services would include:
- Screening for gestational diabetes
- HPV testing as part of cervical cancer testing for women over 30
- Counseling on STDs
- Counseling and screening for HIV
- Contraceptive methods and counseling
- Screening and counseling to detect and prevent interpersonal and domestic violence
- Yearly well-woman preventive care visits
- Lactation counseling and equipment to promote breast feeding
The Food and Drug Administration is proposing guidelines for certain kinds of smartphone applications including ones that are used as accessories to medical devices already approved by the FDA, as well as apps that transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. The agency is seeking public comment over the next 90 days. >>RELATED: Public Health: There's an app for that
A recent study in the Archives of Surgery found a significant drop in surgical errors at Veterans Administration hospitals between 2006 and 2009, compared with the error rate between 2001 and 2006. The researchers say teamwork, an emphasis on safety and better communication account for the improvement.
Could the rocketing use of smartphones be a boon for population health surveys? Trent Buskirk, an associate professor of biostatistics at the St. Louis University School of Public Health, thinks so.
At a panel about Innovations in Population Health Surveys at AcademyHealth's Annual Research Meeting, Buskirk noted that the opportunity to use smartphones for surveys is increasing now that 85 percent of U.S. households have a cell phone--and 37% of those cell phones are smartphones.
Added to the opportunity is the increasing use of health care apps that many consumers are now using which creates a data collection opportunity. Survey researchers could ask app developers for data, such as how many people downloaded a smoking cessation app.
Buskirk says the prevalence of apps also give researchers a model for a survey tool for smartphones, since so many users have now become accustomed to app functionality.
Buskirk and colleagues conducted a small study that invited computer users already members of an online panel that responded to surveys to reply to a new survey either by computer or iPhone. Buskirk says important findings included:
- Fewer incomplete questions, which is a common problem with most surveys
- Loading time for the first screen on the iPhone takes about a half a second longer than on the computer, which is important to know “because if respondents get aggravated they might drop the survey all together,” says Buskirk
- Surveys may need programming more sophisticated than just questions to support app-like experiences
- Smartphone surveys may be especially useful for hard-to-reach or specialized populations. For example, 61 percent of physicians, Buskirk says, now use an iPhone.
- Smartphone surveys will likely need a “save” option, rather than just a submit button. Buskirk says one responder was in a helicopter while responding and some participants took four days to complete the survey because they work on multiple things simultaneously. “You’ll lose responders if they move to another task and then have to start the survey from scratch” he noted
- Developers will need a new way to track how long people spend on each survey, since a smartphone user population may not complete the questionnaire in one sitting
- Smartphones can also be used by survey professionals in the field, perhaps by downloading data from tracking devices participants use such as how many steps they take or how often they monitored glucose levels.
Weigh In: How long would you spend on a smartphone answering a survey?
Health: There's an app for that.
Technology, data, and innovative health apps will be the focus Thursday, June 9, when the Department of Health and Human Services and the Institute of Medicine hold the second annual Health Data Initiative Forum. The Forum, held at the National Institutes for Health in Bethesda, Maryland, will bring together more than 500 people to showcase how health data can create tools and applications to support more informed decision-making by consumers, patients, health care systems and community officials. NewPublicHealth spoke with Todd Park, Chief Technology Officer at HHS, about the forum.
NewPublicHealth: How is the conference different this year?
Todd Park: A year’s time makes a substantial difference in turn out. There has been a lot more activity as the ecosystem of innovation has grown. First of all, HHS and partner agencies of the federal government have been liberating broader and broader swaths of data. For example, last year the data was really oriented toward community health performance and quality. The kinds of data that are going to be demonstrated on Thursday as incorporated into solutions on how to improve health and health care--it’s much more diverse, much broader--a deeper array of data than last year. And the range of solutions that are going to be demonstrated and discussed are similarly much more diverse and broader and deeper just because an additional year has passed.
NPH: What are examples of government data that is available for use now?
Todd Park: I’ll start with community health data. We launched something called the Health Indicators Warehouse. It was launched in February of this year. It’s a website that contains national, state, regional, and local community health and health care performance metrics, as well as drivers of health. For example, smoking rates, obesity rates, rates of access to healthy food. It includes over 150 Medicare indicators of prevalence of disease, utilization of services, quality and prevention at the community level, which Medicare has never released before.
NPH: The County Health Rankings make use of government data to compile their rankings. How has this project demonstrated how government data can be used to improve community health?
Todd Park: I think the County Health Rankings is one of the best applications of government data to help mobilize action and improve health performance. The stories I’m hearing about communities gaining additional awareness of their health performance through the rankings and mobilizing local action to improve health have been absolutely terrific.
NPH: What is a new data tool you’d like to highlight?
Todd Park: Another type of data that we actually are liberating is provider directory and quality data. iTriage was an app that was part of last year’s forum. It’s a really cool mobile and web app that helps users research medical situations and find providers. Last year for the forum, they integrated community health centered data that we had made newly downloadable and it was incorporated into the app so community health centers started popping up as options. And thousands of iTriage users have found community health centers through the app as a result. The idea is that instead of making people jump out of their work flow to go to another web site entirely, bring the data to a platform where people already are searching for health information. It strikes me as a much more effective way to do this. And iTriage this year is going to be demonstrating the incorporation of mental health provider data into their platform.
NPH: What else would you point to?
Todd Park: There are going to be over 45 applications demonstrated at the Forum. And there were many more that we would have liked to fit in--we just literally didn’t have the room, [like]:
* Finding healthy food in a food desert
* Clinical trials based on location
* Applications that help providers find and communicate securely with other providers
* Apps that help local leaders--like mayors and county commissioners make better informed decisions
NPH: How is the government-generated health data used beyond apps?
Todd Park: Healthdata.gov is the site that we launched in February that is the universal inventory of all the data that we’re making publicly available. On healthdata.gov, there is an apps expo run by health 2.0, which showcases a growing array of examples of applications that leverage health data to do useful things. The health data is going everywhere. It’s going into a lot of the apps in the app stores, on smart phones. But, it’s also going into services, products, and programs that are just really diverse, and being harnessed by innovators in ways that are very powerful and very subtle. It is making products and services more effective with better data to help do a better job of helping patients and consumers and doctors and employers and millions of other folks who can benefit.
NPH: Where is a place where a public health department might find applications or new technologies that would help them improve the delivery service or information retrieval to an entire community?
Todd Park: There are actually going to be apps and services on Thursday along those lines as well. For example, there’s an application service called Network of Care for healthy communities. It’s a service that can set up a public website for any community that allows citizens to easily see where they are in terms of health status on key indicators versus where they wanted to be. They can find out what other communities are doing to help improve performance on that particular indicator. The web site also makes resources available online to individuals who are looking for help on particular health issues. And ESRI is going to be debuting a new tool called Community Analyst, which is also meant for people looking at health at the community level.
Read previous NewPublicHealth.org Q&As with newsmakers and difference makers in public health.
What's the latest in health services research and current health policy issues?
You'll be able to find out at the AcademyHealth Annual Research Meeting, which takes place June 12-14 in Seattle. The annual meeting has been the premiere forum for health services research for close to thirty years. Key topics this year include health reform and using social media to disseminate research.
At the conclusion of the meeting, the Public Health Services Research Interest Group, funded by the Robert Wood Johnson Foundation, will be celebrating its tenth anniversary. Speakers include Debra Pérez, M.A., M.P.A., Ph.D., Interim Assistant Vice President for Research and Evaluation at the Foundation. You’ll be able to follow coverage of the conference here on NewPublicHealth.org.
In advanceof the Annual Research Meeting, NewPublicHealth spoke with Lisa Simpson, M.B., B.Ch., M.P.H., president and CEO of AcademyHealth, and David Colby, Ph.D., vice president of Research and Evaluation at the Robert Wood Johnson Foundation.
NPH: What are the key topics that will be discussed at the Annual Research Meeting?
Dr. Simpson: There is a rich set of presentations this year, as in other years. We’re lucky to receive terrific abstracts and presentations. One area where I’m particularly interested to hear and learn more is around what’s happening at the community level and the efforts on the ground to transform the delivery system. Some of those efforts are working very collaboratively with local public health and reaching beyond the traditional boundaries of medical care. For example, understanding how health information technology and different payment approaches are facilitating these newer organizational financing and collaborative models.
NewPublicHealth: From both your perspectives, can you talk about the intersection of health services research and public health services research?
Dr. Simpson: This is the tenth anniversary of the annual meeting of our Public Health Services Research Interest Group and we are reflecting on the progress we’re making in this field, how much public health services research is part of the family of health services research and how integral it is to advancing health. We have to have evidence to improve the delivery of care and the prevention agenda for population health. That’s where I think the future is going. I would also comment that increasingly we’re seeing alignments and recognition within the more traditional medical care delivery system of the need to focus on population health and the need for partnership and even more collaboration between the health system and the public health system.
Dr. Colby: Health services research is a young field and it’s a field that is interdisciplinary. So the boundaries around health services research are more like a fuzzy set than a brick wall. We have a strong tradition of looking at delivery, quality, and access in the medical care system. Yet the goal of many members of AcademyHealth, as expressed by David Kindig, M.D., the former chair, is to study how to maximize the health of individuals and the health of populations. The AcademyHealth board adopted a definition of health services research which included the impacts of social effects and personal behaviors on health and well-being. This means that research needs to focus on all the inputs into health from the health care system, personal behavior and characteristics, and the environment. There is a recognition that you have to take into account all of these things to influence people’s health.
Dr. Simpson: I agree with David. As a pediatrician we especially focus on factors outside of medical care and the health of children in particular is so dependent on that multidisciplinary approach to understand what works to maximize and optimize health outcomes for children and their families and their communities. There really are those fuzzy boundaries.
NPH: What is the conversation that needs to take place between health services delivery and public health?
Dr. Colby: Articles written in the early 1990s showed the most important inputs into the health of the public are not from the medical care system. If we want to improve the health of Americans, we have to be working on those areas that will produce the most leverage, and that is improving where people live, learn, work and play.
Dr. Simpson: As we think about public health, increasingly I think that we understand that what contributes to the health of the public goes well beyond public health departments or what is traditionally thought of as the institutions of public health. We’re seeing employers having a dramatic stake in public health, promoting employee wellness and health promotion and disease prevention. We’re seeing the health care delivery system moving more and more toward health as part of the triple aim which focuses on improving population health, the patient experience of care and cost. It is about how communities exist and structure their community institutions well beyond public health and health delivery--from transportation to food, the environment and the built environment--all of these contribute to achieving the health of the public--and so health services research is expanding its methods, approaches and data sets to bring in information that captures the dynamics and influences on the child, the family, the community. In that way, we are better able to tease out and understand the policy levers and the interventions that can optimize health outcomes.
Dr. Colby: One example is that the Federal Reserve became very interested in the impact of community development on the health of Americans. They have held several conferences around the country about the interface between what they do in housing and other policies and the health of Americans.
NPH: What do you think the Federal Reserve’s contribution can be that another entity might not be able to contribute?
Dr. Colby: When the Federal Reserve starts talking about health issues, it’s a ‘wow.’ The Fed controls significant amount of money that can be used to improve the health of Americans. Where and how you build houses, parks, sidewalks, and grocery stores will have an impact on health of Americans.
NPH: There are two sessions at the annual meeting that are devoted to helping researchers disseminate their findings. Are researchers finding it more or less difficult to get their information out to the stake-holders that need it and then make its way to the field?
Dr. Simpson: I think the answer is, like so many things in health policy, it depends. Our field is growing and vibrant. Our membership is at the highest point ever, almost 4,500, and we represent a very diverse field.
I think that there are many journal opportunities, and depending on which journal you’re working with, the competition and the difficulty in getting your work published in an academic journal varies tremendously--as might the delay in publication between when you have your findings and when it actually appears online. But I think that increasingly, researchers are recognizing that there need to be, and there are, many other venues for getting their findings into the hands of the decision makers who need evidence.At the same time, journals are moving toward more timely reviews and expedited online publishing.
There are also many other ways that researchers have been working increasingly to get their evidence into action--and we support a number of those methods. For example, learning networks where we identify a policy need and researchers and experts who have been publishing and working in that area and we bring them together. These networks create an opportunity for a researcher to very directly inform policymakers about their area of expertise and passion. Another example is the HCFO--Health Care Financing and Organization--a program of The Robert Wood Johnson Foundation managed by AcademyHealth. As the national program office for HCFO, we bring researchers together with their targeted users and audiences in small, focused discussions where you can really delve deeply into what is known and what is not. These sessions not only get information to the user more quickly, they actually help the researchers better understand what evidence is most needed. So, together with our members, we are really looking in very different ways to achieve our goal of moving knowledge into action.
NPH: Canyou talk about the impact of social media on evidence dissemination?
Dr. Colby: Health services researchers have to get used to social media for three separate purposes. One purpose is getting information out to people. Reporters follow tweets and that’s where they pick up some emerging stories. Obviously, the reporters will call up and get more in-depth information beyond 140 characters but Twitter provides the lead.
Another purpose is that social media tools are going to provide data for health systems researchers. For example, a project that we funded published an article on following tweets to figure out the impact of certain diseases, and an earlier article we funded used Google searches to show the spread of a disease. These studies represent a new epidemiology, which lets you know what’s going on before you get the official records.
Finally, I think that these social media tools are going to be very important in helping people improve their health. You could have an app on your phone that reminds you that you have to do specific things on a daily basis to improve your health.
Dr. Simpson: To build on what David has said, we see social media as the newest tool in our tool kit to support our mission of moving knowledge into action. I think there is enormous potential for the field to embrace these technologies and push them even further. In fact, one of the things that we’re announcing next week at an Institute of Medicine meeting around newly available data, and also at the Annual Research Meeting, is the REACH--Relevant Evidence to Advance Care and Health--Challenge. The REACH Challenge, which we are sponsoring in partnership with Health 2.0, offers a prize of $5,000 to a team of researchers, developers and other specialists who takes evidence-based research and data and translates them into an application that advances health and care.
This is really the future. Apps and social media are clearly an exciting new strategy for evidence dissemination and a new way to reach the audiences we need to target.
AcademyHealth has focused a lot more on social media in the last couple of years. You can follow us on Twitter, at @academyhealth or with the hashtag #ARM11 for the annual research meeting. We also have a blog at blog.academyhealth.org. And also new this year at the Annual Research Meeting is what I call "American Idol meets AcademyHealth," where we’re asking people at the meeting to choose their favorite poster presentation for inclusion in a first-ever “virtual poster session” by texting their vote to us. So we’re really trying to expand our approach and the various methods we use to engage our various audiences. At its core, it’s about matching up the content and the evidence with the medium and the messenger and the audience, and aligning all of these points so you’re delivering the right information in the right way to the right customer at the right time.
NPH: Will you both be tweeting at the meeting?
Dr. Simpson: David will be tweeting and I’m going to start learning how to tweet at the meeting!
Read previous NewPublicHealth.org Q&As with newsmakers and difference makers in public health.
A recent study blame cars for the some of the increasing obesity in the U.S.—Americans are driving more, and walking less, resulting in extra pounds—and health risks and problems.
But the Ford Motor Company thinks it can help create some positive health outcomes during the time people spend in their cars. The car company has teamed up with several healthcare companies to create a system that would let drivers monitor health measures or vital health information from right behind the wheel. The idea builds on a technology already in many Ford cars--Ford SYNC, which lets drivers control certain features, hands-free, like interior temperature and radio volume, from the steering wheel.
Health capabilities on the drawing board include:
Glucose monitoring: Ford researchers have developed a prototype system that allows Ford SYNC to connect via Bluetooth to a continuous glucose monitoring device made by Medtronic, a medical device company. The system can send an audio alert to the driver if glucose levels drop too low.
Allergy alerts: Ford is working with health analytics firm SDI Health to give Ford drivers voice-controlled access to “Allergy App”--a pollen data app, which would give drivers location-based pollen count reports and four-day forecasts.
Health Management: Ford is working with a disease management technology firm, Welldoc, Inc., to build into the SYNC system the ability to update patient records connected to the system with any measures captured during time in the car. And those updates can also trigger the system to send reminders, such as an upcoming medication dose.
Health features could be added to cars within two to four years, some perhaps sooner, says Alan Hall, a spokesman for Ford. The Sync technology is available in many Ford cars right now, and can be added on many models for an additional $395. Added costs might kick in for some apps and services.
Weigh In: What health measures would you like to see built into passenger vehicles?
Heading into a very special Mother's Day weekend, NewPublicHealth pulled together some links and resources that celebrate Moms for everything they do to keep us healthy, wealthy and wise.
- National Women’s Health Week kicks off on Mother’s Day. The site offers save the date e-cards; free events throughout the country, including free gym passes; a resource list on health issues that most concern women; and a printable chart (PDF) with concise information on how frequently women need specific screening tests and vaccinations.
- Send free Mother’s Day e-cards from the Centers for Disease Control and Prevention that offer healthy behavior reminders.
- Check out these safe teen driving kits including a video and a pledge that teens can share with moms—and dads.
- Send mom this link to http://www.healthfinder.gov. The site, hosted by the Department of Health and Human Services, includes a podcast series on managing work and home life; online checkups; fitness logs and planners; and cool health widgets.
- Health-based phone apps makes great gifts.
How healthy is your smartphone?
There are thousands of health apps available on the market. A few free ones from national public health organizations are definitely worth checking out:
- An American Association of Poison Control Centers app that links users to a local poison control center (currently available on iPhone only, but in development for Android, Blackberry and Windows-based smartphones).
- An NYC Condom Finder app, from the New York City Department of Health and Mental Hygiene, that helps reduce the spread of sexually transmitted diseases by showing users the nearest place to get free condoms (available for iPhone and iPad).
- An app from the American Heart Association that lets users find and track walking paths (available for Android, coming soon for iPhone).
- UPDATED: A commenter let us know about the Harvard Public Health School app: "With the HSPH Public Health News app members of the Harvard School of Public Health community and others can connect with each other and stay up-to-date on breaking public health news and research, plus events and activities going on around the School." Great addition!
- UPDATED: The CDC is engaging the public health community to come up with an app that promotes healthy behaviors to help prevent the flu. The agency has launched the CDC Flu App Challenge, which closes May 27th. The CDC will be giving out $35,000 in prizes for the most innovative apps that use CDC flu data. Winners will be announced on June 8.
Though it will take time to determine what sort of health apps are most effective, health organizations will definitely continue to develop the smartphone tools, says Lorien Abroms, Sc.D., an assistant professor at the School of Public Health and Health Services at George Washington University in Washington, D.C.
Abroms recently published a study in the American Journal of Preventive Medicine that reviewed 47 smoking cessation smartphone apps available two years ago on the iTunes app store. The study looked at how well the apps complied with the U.S. Public Health Service’s 2008 Clinical Practice Guidelines for Treating Tobacco Use and Dependence. Most of the apps fell short. Three that complied with at least one guideline could not be recommended due to poor “ease of use” or poor breadth of content. But Abroms says she expects better-executed public health apps to make their way to the market soon.
Abroms offers criteria for judging public health apps:
- They should be developed from evidence-based guidelines for behavior change in that area (e.g., the U.S. Public Health Service Clinical Practice Guidelines)
- They should offer periodic messaging/alerts to guide behavior change (Abroms says that while we have little evidence about guiding behavior change with smartphone apps, through research on text messaging we know that periodic messages can help with smoking cessation, weight loss and diabetes management)
- The app should offer the opportunity to get social support for behavior change
- If possible, the apps should provide links to other proven services (e.g. a quitline)
Weigh In: What's your favorite public health app? Tell us in the comments.