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Health Apps - Dr Federica Lucivero

Fede

Dr Federica Lucivero

Federica’s research investigates the ethical and social aspects of digital and mobile health, with a particular focus on the way portability of healthcare redefines normative boundaries in medicine and beyond.  

Federica’s PhD thesis, completed in 2012 at the department of Philosophy at the University of Twente (The Netherlands) addresses the methodological question of assessing the plausibility of expectations surrounding emerging technologies within the context of Technology Assessment. From 2012 till the summer of 2014, she was a post-doctoral researcher at Tilburg Institute for Law Technology and Society (University of Tilburg, the Netherlands)  where she was exposed to theories and studies of technology regulation.

She joined the department of Global Health and Social Medicine in September 2014 as Marie Curie Fellow. Her project explores the ethical and political underpinnings of mobile health. Federica is Affiliate Member of the 3TU Centre for Ethics and Technology and member of the Centre for Ethics and Politics of Emerging Technologies (CEPET, hosted ad Maastricht University, NL). She is an Associate Member of the ALERT Research Group at Middlesex University, investigating the  Aspects of Law and Ethics Related to Technology.  

Because of her expertise on patient experiences and empowerment through mobile health technologies and electronic access to medical records, Federica is currently representing KCL in a Working Group that the European Commission has recently established to draft guidelines for health apps quality assessment. 

 

Transcript

Hello I am Nigel Warburton joining me today is Federica Lucivero a European commission sponsored research fellow in the department of global health and social medicine at Kings College London. The topic we are going to talk about is Health Apps, let’s start by getting clear what a health App is. 

So a health App is a piece of software that runs on a smart phone or a tablet and that is used for health or wellbeing purposes. It’s a very big definition the way I am putting it because when we talk about health Apps we do refer to many very different things. 

So this might be something that measures your pulse, it might measure your blood pressure or it might measure how many hours sleep you had the night before?

Yes, but it could also be something, an App where you can find information about a certain condition, it could be an App that you can use to book an appointment with your general practitioner or to check specific conditions. So it could be an education tool for medical students or a consultation tool for doctors.

So it seems to me we are living in an age where there has been an explosion of this kind of thing, that suddenly in the last ten years there has been any number of these Apps emerging on the market.

Absolutely, when I first started with my project the numbers were like 97,000 Apps were available on the market, this was 2013. And the prediction at the time was that by 2017 the market will be up to 26 billion dollars in this field. So many, many big companies have been investing in this field. And recently different governmental bodies have been looking at these Apps because they have started realising that they really need to start regulating them.  

So presumably different Apps require different kinds of regulations so something which is used specifically in a medical context needs to be closely monitored for accuracy and so on. But something which is just a general health App would that really need to be regulated? 

Well that’s exactly the question, and it’s a very important question nowadays because the initial idea and the initial position by bodies like the Food and Drug Administration in the United States, but also by regulatory bodies in the UK. So the initial idea was yes if the App is not related to a medical device then it doesn’t have to be regulated.  Things have been shifting because what has been noticed is that there are some Apps that do not fall under the definition of medical device but they still raise questions about quality. Because they are still dealing with health data. 

What sort of thing are you talking about here? 

Simple Apps used by many of us, for example at the beginning of this year the  data protection authority stated that the data that is used and collected and processed by fitness Apps used by runners for example, they are still dealing with health data and should therefore make sure that this type of data is protected. This then means that if our running habits are health data what is not. And in that sense I am saying even fitness and wellness Apps require specific attention in terms of the quality, quality with respect to the way data is protected and people’s privacy is protected. Because of course if we can infer something about people’s health from running data then this mean also this data becomes sensitive. But also quality related to the accuracy of the information produced by this App. 

That’s really interesting, so you are saying that fitness Apps the data can imply things about somebody’s health or they may actually capture health related data. And because of that they should at least be considered as part of the medical world or should fall under medical regulation? 

Well not necessarily under medical regulation but they should be governed. It cannot just be said that these are consumer products.  We do need a way to assess their quality.  

Are you saying there isn’t a real clear distinction between medical Apps and more generally health Apps? 

I am saying there are clearly medical Apps and then there is a huge grey area of Apps that are in-between. And I think it is this hybridity of Apps that are not clearly medical Apps but can be used in a medical domains. Or Apps that are used in health related domains, in fitness and wellness domains. It’s exactly this hybridity of Apps that is causing I think interesting debates, you know at the level of governance of these Apps. And it’s also created a lot of questions for App developers who don’t quite know what type of regulation they should adhere to. Or with respect to doctors who do not know whether they can advise patients to use some Apps or not. And patients, imagine a patient who is having sleep disorders and they want to use, there are so many Apps available for people with sleep disorders, how do you know what is a good Apps there are so many available.   More than that the truth seems to me that we live in this age where Apps are proliferated and they are giving us a kind of self knowledge about various aspects of our behaviour that we never had access to before and nobody really knows what to do.  Yes absolutely and as I was saying before, it is this hybrid nature of the Apps that I found particularly interesting, it is the fact that some of them are in-between the domain of what is health and what is medical and what is life style and kind of consumer product. And you know this distinction has never been so stark, everything that pertains to our life is in-between our lifestyle and does pertain to our health. But the interesting thing is that the distinction has been used to regulate specific aspects of our life in terms of liability, in terms of health insurance, reimbursement policies, in terms of certifications. We try to distinguish what is medical and what is not. An interesting thing is that all these Apps that have popped up in the last three years are really challenging these existing distinctions and the governance tools that we have.  That requires us really to rethink about the role of the distinctions and what about what is medical and what is not that is really relevant.  

Do you think the existence of health Apps changes the nature of medicine and what counts as medical? 

Yes I think it does, the fact that people have such a wealth of data available. The fact that there is more and more marketing by big companies about how you can know yourself better through this data, through the graphs that they produce for you. This does change it, so there is something about the way we know ourselves, the way we understand disease. But there is also something about the way we deal with it, that is something about self management. Because these Apps not only give information but they also tell people how to deal with this information. They advise people on actions that can be taken and so on. So it’s this whole idea of what is the role of the doctor and what is the role of the patient, and how the patient requires some expertise that before was just left to the doctors. And I am not claiming that this is only happening with health Apps, some of the strengths are recognisable in other domains as well and because of other technologies. But I found this is particularly striking.  

It seems to me that one aspect of this is that the patient or the individual user of an App is empowered, or at least has the illusion of being empowered by the information, by the new access to stuff that was always the province of a doctor before. 

Yes, that’s what many App providers and App developers promise, the promise of empowering patients is really dominant in the rhetoric and in the marketing of these Apps. The problem is what is the meaning of empowerment in this context. We are empowered when we can do something, when we have the power of doing something. Having a graph or having some details about your sleep patterns, or having some details about your habit doesn’t necessarily empower people to do something about that.  And I am not saying that every App is guilty of not empowering people, what I am saying is that its sometimes a too easy rhetoric to say that having this information at  hand or in your pocket will empower patients. In order to empower patients I think the entire system that needs to adapt, the entire system that has to allow patients to play a role a more active role in their care. 

Federica Lucivero thank you very much.   

Thank you Nigel 

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