Today, we welcome back Priya Kumar, a digital researcher from the University of London for part two of an interview on mobile health. If you missed part one, you can catch up here.
LK: What issues surround the ethics and governance of mHealth?
PK: As I mentioned in the first part of this interview, we expect that by 2017, 85% of the world’s population will be covered by a commercial wireless signal (1). Wireless networks cross state borders. However, ethics and governance mechanisms for virtual technology are still unclear, and particularly so for apps on hand-held devices. A notable instance was in September 2013, when the FDA released guidance for the developers of mobile medical apps. They defined ‘mobile medical apps’ as those which are intended ‘to be used as an accessory to a regulated medical device’ or ‘to transform a mobile platform into a regulated medical device’ (2).
These criteria are defined so that the majority of health apps are not considered ‘mobile medical devices’ and are therefore not FDA-regulated as ‘they post minimal risk to consumers’.
A study published in the New England Journal of Medicine in July 2014 discussed that only about 100 out of about 100,000 health care apps are FDA approved (3). According to the article, members of US congress and industry are lobbying for even less regulation of mHealth, with the worry that ‘applying a complex regulatory framework could inhibit future growth and innovation in this promising market’ (3,4).
The ownership of health data collected through these apps is unclear. Different from other apps that automatically share your data, health apps often require the user to sign off to third party sharing (such as allowing you Apple HealthKit data to be shared with the WebMD app), and here informed consent becomes an issue. This question also relates to privacy and data security issues.
The new HealthKit on the latest iPhone operating system claims to store health data in a separate place ‘away’ from the cloud, but we as the public don’t really know where this ‘away’ is or how secure it is.
On the marketing side, there are still many questions about intellectual property, the idea of competition, and whether health care service should be something we’re competing over or not. Digital ethics are constantly evolving country to country. There are over 150 countries that have yet to develop any kind of regulatory framework for apps. A one size fits all model is not possible for mHealth. Every country has a unique health system, which these apps must fit with.
LK: If mHealth apps are used a tool for health management, what could this mean in the context of private and public health systems?
PK: Health apps can allow us to address gaps in institutions, in service delivery, and in public knowledge. All of these things can be facilitated through a simple download. Applications targeted at patients, such as in cancer or HIV/AIDS can be very useful in providing automatic medication reminders, dosage information, and mobile support groups. The first HIV/AIDS app to come out on the market was from the UN (UNAIDS) in June of 2011. The UN app provides HIV/AIDS fact sheets for 129 different countries, with charts of epidemiological data on HIV/AIDS and the number of individuals taking anti-retroviral drugs. This UN app, in a way, shrinks space through infiltrating global consciousness with the international priority that we have given to HIV/AIDS.
There are other functions of HIV/AIDS apps as well. One is called ‘Facing AIDS’. It allows you to take a ‘selfie’ and upload it to the app to show how you are personally ‘facing’ AIDS. The picture can be of you, a family member, a friend, anyone affected the illness, and it can be shared across your social media platforms. The purpose of the app is to reduce the stigma surrounding HIV/AIDS and make it more visible. There is also ‘inPractice HIV’, which is an app for health care professionals. It gives guidance for patient care, provides an FDA approved drug database, and research abstracts from PubMed. Then you have ‘PozTracker’, which is a personal HIV management app, which allows you to track your medication needs, monitor your test results, and time your medication dosages. This app creates your personal history as an HIV patient.
mHealth apps address HIVS/AIDS at multiple scales from international organisations to your doctor’s clinic and your own social network.
An interesting facet to how these apps are used is the in-store user reviews. As an HIV/AIDS patient, apps are reviewed and vetted by your global community and that carries a lot of weight. These discussions about illness happen in real-time, and that shrinks the world in a way. The only ethical issue I would raise is that the benefits of these apps depend on how they are treated in the social context of the countries in which they are used. Wireless networks transcend borders, but not every country has the same health system and health care policy.
LK: Who is at risk of misuse of mHealth apps, and on the flip side, who is the most likely to derive real benefit from them?
PK: The most obvious negative consequences can be oversimplification of health issues, developing hypochondria, and also questions of accountability. If we follow the guidelines given in a health app and something bad happens, who is accountable? In this way, apps can disturb the traditional primary care model of health delivery. A commonly reported misuse is in melanoma detection apps. In principle, they appear to be very easy, you take a snapshot of a skin mole and it calculates the risk that it may be cancerous. But, the best practice is to see a doctor for consultation. Another example is apps to aid in breast self-examinations. These apps offer self-examination tutorials and alarms to remind you to do your self-exam. Although these apps can provide useful information about the symptoms of breast cancer, at the end of the day, any health care provider would say that self-examinations do not replace a mammogram (5). If self-examinations are not recommended, then what message does that send to people who are downloading and using these apps?
LK: That’s right, we place a lot of trust in the information that we receive online, particularly if we receive it via the Apple store. There is some kind of legitimacy associated with the store, particularly if an app is well designed and looks nice. Also we place a lot of trust in the health domain, we trust doctors and maybe we implicitly see these apps as an extension of that.
PK: Exactly. The public is being misinformed in this instance. On the one hand, the US National Cancer Institute says that routine breast self-examinations are not effective in reducing mortality from breast cancer, (5) but on the other, the Apple store give us multiple apps you can download to help with your regular self-examination. The medical accuracy of these apps needs to be validated.
LK: That’s where FDA or other regulatory approval should come in.
PK: Yes. I would say that with respect to the ‘reach’ of apps, it’s too early to draw any conclusions on the positive or negative sides of these apps. We might have more information and we might be able to hold our health care providers accountable through harnessing our own power through these apps, but we have to be responsible. Second of all, and perhaps most importantly, within the next year there are going to be 500 million smartphone users newly using health apps (6). We really don’t know the long-term behavioural impacts of these health applications. Even just having certain apps embedded in our phones upon purchase impacts our day-to-day behaviour. That’s where I think health sciences can play a role. There are clinical trials currently collecting data through Apple’s HealthKit, so we have to increasingly acknowledge that there is a behavioural component of these apps. There is a patient-consumer-producer relationship that we need to figure out. And that’s not going to happen right away.
LK: What the directions that we need to take, as researchers, looking forward?
PK: I think that all researchers who are interested in virtual technologies need to collaboratively develop effective tools to capture the depth and scope of these technologies. And to do that will be very difficult. To capture the intricacies of these phenomena, to capture both sides of the screen and be able to see the transformative impact of online technology will require a more collaborative relationship between qualitative and quantitative methodologies.
We are going to have to reshape our methods, with the understanding that scientists using pre-formulated hypotheses do not generate virtual data; rather, virtual data are user-generated and purely observational.
And for a lot of researchers that may be a little bit threatening. That’s the nature of these applications. Whether or not health researchers and even social scientists may not like subjective or user-generated data, the reality is that these are now being looked at.
LK: Any final words?
PK: The final thing I would say is, as researchers, we need to understand that the iPhone or Smartphones are now the standard. For people younger than us, something like the HealthKit is normal, nothing special. The market monopoly of the iPhone means that the HealthKit has the potential to infiltrate our everyday behaviours in ways that we may not even consider. That’s where you see the boundaries of scientific data slowly expanding, and it’s user generated. Finally, another really interesting future question ethically would be if we look at mobile providers. They actually cut the population. As a virtual researcher, the first thing I think is that if we look at health apps, we’re looking at a Samsung device or an iPhone, for example, and it may be that these service providers are able to cut populations into different datasets. Samsungs don’t have the HealthKit. Only the iPhone has it. So Apple may end up having a dataset that Samsung doesn’t have, and vice versa. Whether or not we want to engage with these market and consumer realities from a theoretical and academic perspective, we have to acknowledge that they are there and they will shape our data. In that way, there is a lot of research potential and we really need a lot more collaboration between social sciences, health sciences, and public policy and governance as well.
- Savitz E. Ericsson: 85% global 3G coverage by 2017; 50% for 4G. Forbes. 6 May 2012. http://www.forbes.com/sites/ericsavitz/2012/06/05/ericsson-sees-85-global-3g-wireless-coverage-by-2017-50-4g-coverage/ (accessed 12 October 2014).
- U.S. Food and Drug Administration. Mobile medical applications: guidance for industry and Food and Drug Administration staff. U.S Department of Health and Human Services. 2013. http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf
- Cortez NG, Cohen IG, Kesselheim AS. FDA regulation of mobile health technologies. N Engl J Med 2014;371:372-9.
- Letter from Representative Marsha Blackburn et al., to Margaret Hamburg, FDA Commissioner, and Julius Genahowski, FCC Chair. 3 April 2012. http://blackburn.house.gov/uploadedfiles/letter_from_congress_to_fda_and_fcc_-_3apr2012.pdf
- National Cancer Institute at the National Institutes of Health. Breast Cancer Screening (PDQ®). http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1 (accessed 15 October 2014).
- U.S. Food and Drug Administration. Mobile Medical Applications. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm255978.htm (accessed 15 October 2014).