Personal health records in Europe: National or beyond?

Personal health records (PHRs) are not a new invention. They have been with us since the early 2000s, but in many cases didn’t really take off.
By Philipp Grätzel von Grätz
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doctor looking on tablet at personal health records

There are dozens of PHRs that survived only a couple of years, most famously, of course, Google Health. But PHRs are back now. Many European countries have launched ambitious PHR projects. Mobile access is widely tipped to be a game-changer in terms of acceptance by citizens. Furthermore, the EU General Data Protection Regulation leaves little room to approach lifelong medical data storage in any other way than with a highly patient-centric approach.

True as all that might be, building sustainable PHRs remains a challenge. What is the long-term vision? What data exchange standards should be used? How should structured data and thus semantics be approached? What about cross-border healthcare? Insights has asked two European champions of digital healthcare, who approach PHRs from slightly different angles, about where PHRs are (or should be) heading to. Erik Gerritsen from the Dutch Ministry of Health is busy in implementing a PHR, or in fact many PHRs, on a national level in the Netherlands. And Bogi Eliasen from Denmark thinks beyond national boundaries and envisions a future in which PHRs meet personalised medicine.

"Working towards interoperability, we are trying to provide the fertile ground necessary to make the digitally empowered patient reality."

Erik Gerritsen, Secretary General at the Dutch Ministry of Health

Defending motion - 'Involve the patients'

Standardisation and interoperability are challenges that every healthcare system that is trying to establish digital patient records of whatever kind has to address. Often enough, standardisation discussions are taking over at some point though. The Netherlands are trying to avoid this trap by following a strictly patient-centred approach to their personal health record standardisation efforts in the MedMij project, which is quickly approaching implementation phase. Erik Gerritsen, Secretary General at the Dutch Ministry of Health, Welfare and Sports, has the details.
 

Q. What efforts are underway in the Netherlands to engage citizens and patients digitally?

The Dutch government is trying to make sure that patients are in the driving seat in as many areas as possible. Shared decision making is the minimum, but when we think about how to implement innovation, for example, it goes way beyond that. Patients should not only come in as an advisor after the fact, but they need to become an integral part of the innovation process. For a ministry like ours, this is not so much a matter of policy or laws but of being the champion of these principles. For example, you can only get a subsidy as an eHealth project when you are patient-included. The patient is an underestimated force in the inherently conservative healthcare systems all over the world. Empowering patients helps to speed up the innovation process.

Q. What role do personal health records play in this context?

We like to think of digital healthcare as an ecosystem. For this to flourish, you need fertile grounds and a positive climate. In terms of positive climate, we facilitate health deals by bringing all parties together. We review and adapt rules and regulations that are perceived as inhibiting innovation. We also have seed capital arrangements in place together with the Ministry of Economic Affairs for start-ups who want to scale-up. PHRs or ecosystems are in our understanding part of the fertile ground. This is about standards, interoperability, and secure communication. It is great to have access to your own hospital record via a portal, but sooner or later, you will start to get lost in all the portals. By working towards interoperability, we are trying to provide the fertile ground necessary to make the digitally empowered patient reality. 

Q. How exactly are you approaching PHR interoperability in the Netherlands?

Interoperability is the real big challenge. And it is not only about technology. That’s why we have established an information council that I am chairing and in which the whole Dutch healthcare system is represented. Hospitals, long-term care organisations, medical specialists, nurses, general practitioners and patients are literally sitting in one room. And they are not only trying to agree upon standards, but also discuss about how best to implement them within a timeframe of three or four years and based on our MedMij project. It is easy to decide that we use FHIR or IHE or HL7, but a decision like that – important as it is – does not automatically mean that these standards are actually implemented. Our goal is that within three or four years, a supplier will go out of business if he doesn’t have its information system interoperable. This is also a matter of quality of care, by the way. 

Q. What is MedMij about, and how does it relate to the broader interoperability efforts?

MedMij is a technical framework that aims at creating a market for personal health environments, which are absolutely critical from a patient empowerment perspective. There are numerous systems that are primarily focused on professionals. Patients need to be allowed access to these systems, and as a government, we are working on that. But in addition, we are trying to solve the problem of how to make a patient actually the CEO of their own health data.

That’s what MedMij is about. It will, hopefully within three years, create a market for personal health environments. These are apps that connect with your mobile devices, with the hospital, the pharmacy, the GP system etc, so that you as a patient are the only one with total oversight about the information in the different systems. You alone can decide with whom you want to share data. MedMij is not the app itself, it is the system of arrangement and standards. We will provide a MedMij certification, so that people will know if a system is not MedMij approved and should better not be used. In the end, we strive to make MedMij certified apps free for patients as part of the standard insurance packages. 

Q. How are the suppliers reacting? You are forcing them into an architecture. Do they like it?

Most of them like it, in fact. There are some suppliers that are not so happy. These are suppliers for care organisations that provide IT solutions with characteristics of personal health environments. But if this is a closed shop solution, it runs against our philosophy of you as a patient owning the data and having the option to choose whatever personal health environment you want to use.

Q. How many MedMij conform apps are you expecting?

We don’t know, honestly. Two would be too few to have a competitive market. Maybe we end up with five, six or seven. To get there, we will have two temporary subsidy schemes. One will subsidise the suppliers, because they have to invest in an environment with unclear business models. This is why we create an incentive to kickstart the business. It will have a self-correcting mechanism though. Part of the payment will depend on the number of users that an app gets. We expect to keep this subsidy for one or two years, until there is a healthy set of grown-up apps and a market that rules itself with insurance companies who pay. The second subsidy is for the care organisations, because they will have to make ready their information system compatible with the MedMij apps. 

Q. In what ways does the authentication and identification project that you mentioned earlier connect to the MedMij framework?

It will be part of it in fact. Secure authentication and identification is an area where we cooperate closely with the Ministry of the Interior. The Dutch government has an approved authentication system in place. It doesn’t fulfil the highest level of security that will be necessary for personal health environments, though. We are working on upgrading the current system now. Which is interesting, because the higher the security level the less user-friendly it tends to become. In addition, we also invite the market to come up with private authentication and identification tools so that people can choose in this area, too. Banking institutions, for example, could be interested in providing such a solution that they can also use for their banking applications.

Q. So interoperability in authentication/identification is an overarching goal of the Dutch government?

Yes, but it will not be as easy as it may sound. A single sign-on for the whole MedMij platform will probably not be possible. The idea is to open the MedMij app with your finger, but when the app connects to, for example, a hospital, a second procedure will probably become necessary. Some say that people won’t use the system then. We have not solved this problem yet. There is still a lot that needs to be addressed. However, if we wait for all those issues to be solved, we will get nowhere. We are building the bridge while walking on it, and we don’t know for sure where the bridge will end up.

Q. What is the timeframe for the MedMij project?

I think within a few months we will be able to come up with a definite version of the standards. In this case, we will start with the two impulse finance arrangements during the second half of 2018. 

"We need a direct, open, and standardised information channel between individuals who want to provide data and whatever service provider that wants to offer precision medicine services."

Bogi Eliasen, Associated Partner at the Copenhagen Institute

Against motion - 'Don't say national'

Digital health in Europe is still largely driven forward on a national level. In an age of big data analytics and precision medicine, this is far from ideal. Couldn’t we think bigger? What about implementing a truly international digital health network – with patient-centric data management models that are indifferent to the borders of nation-states? The Copenhagen Institute for Future Studies has taken this vision seriously. It has outlined a pan-Nordic, interoperable personal health record landscape that could, if realised, take precision medicine to the next level. Bogi Eliasen, Associated Partner at the Copenhagen Institute, tells us what the Nordic Way is about.

Q. In the Copenhagen Institute for Future Studies’ recent White paper on ‘Person Centric Data Management Models and Opportunities in the Health Sector – The Nordic Way’ you argue that the digitisation of healthcare and precision medicine are closely interwoven. What specific demands must personal health solutions fulfill to become fit for personalized medicine?

If we take the vision of precision medicine seriously, digital information processing is a necessity. Biological knowledge needs to be available in a format that can be worked upon. And we will never get there without closely interlinking digital PHRs with the systems that produce the biological knowledge. In my opinion, it is not so much about tools, but about philosophy. If we talk about precision medicine, we talk about early detection, early intervention and prevention, and this has to be mirrored in the PHRs or other IT systems that we use in healthcare. It implies, for example, that we not only look at the sick, but at healthy people too. We have to broaden our scope of what we consider to be health data. A PHR that is fit for precision medicine will not only archive clinical data but make use of data of all kind locked in your phone and of microenvironmental data that will become increasingly easy to monitor. 

Q. Having more data available alone won’t do. What kind of digital tools, for example in the field of data governance, will be necessary to make digital precision medicine work?  

That’s what parts of our recent White paper are about. A key question for policy makers, of course, is how to get from our current, often fragmented healthcare provision to the new era. A key part is a person centric data management model, as was proposed, among others, by the Digital Health Revolution project that was launched in Finland in 2014. It builds on the principles of MyData, which are human centric control and privacy, usable data, and on open business environment. MyData is a development that at least partly correlated with the European General Data Protection Regulation coming into effect. The basic idea is to enable a free flow of data to get the value out of it while at the same establish a privacy and security framework that gives the individual the possibility to control what is being done with his data. Another key feature is that data have to be easily accessible via open application programming interfaces in order to allow an ecosystem of precision medicine service providers to develop.

Q. In terms of personal health records, are we talking about dynamic consent tools?

Dynamic consent is a natural way of thinking about it, but it should be applied with caution. Most people don’t really care that much how their individual data is used as long as they trust the system and as long as they are convinced that they are getting benefits out of data analytics. It is also important to stress that individual data of a single person does not hold that much value. It is only when we relate individual data to aggregated knowledge that the benefit occurs. In other words, when everybody locks their data away, there won’t be any big data benefit. I think we will need both. Some or probably many people might want to give all their data without requiring feedback every single time the data are used. So this should be offered as an option. Others expect to be asked every single time, and they will probably need detailed consent tools. To start with, what health systems should implement is tools that allow citizens to provide self-collected data in a more dynamic way. We need a direct, open, and standardised information channel between individuals who want to provide data and whatever service provider that wants to offer precision medicine services. 

Q. In your White paper, you are not only backing a digital health revolution guided by MyData principles, but also a supra-national, Nordic digital health landscape. What are the common denominators that make a ‘Nordic’ approach to digitally enhanced precision medicine attractive?

First of all, more or less all Nordic countries rank pretty high on digitisation readiness scales. All these countries have been collecting a lot of healthcare related data about their citizens for many years. There is a high level of trust within the population that healthcare authorities work responsibly with these data. Citizens of Nordic countries are also very open when it comes to participating in clinical trials. So it is an easy area to start, and at least some governments are already used to co-operating with each other on digital infrastructure issues, Finland and Estonia, for example.

Q. But why is it so crucial to have an international approach to digital precision medicine infrastructures? Isn’t it difficult enough to get ahead on a national level?

We should definitely try to bridge the different initiatives in different countries and not stay national. One obvious reason is that the Nordic countries are mostly small countries. But it goes beyond this. A person centric data management model cannot be created solely by a ministry or by a healthcare bureaucracy. It needs to be co-created by the citizens. So we need a broad movement that is bottom-up and that pushes the national governments into the right direction. Public discussions about digital health and precision medicine in the Nordic countries are in a stage that makes such a broad movement a realistic scenario.

Q. One suggestion that the White paper specifically discusses is the “My Nordic Health Card”. What would that look like?

Everybody in the Nordic countries has some sort of a health card already. So it should not be rocket science to widen this in the direction of a tool that allows individuals to share their data and that opens access to aggregated data and to precision medicine services. Every Nordic country has a working health portal of some sort. A “My Nordic Health Card” would allow citizens to get usable copies of their portal data in order to make them accessible, to run artificial intelligence on them etc. It doesn’t have to be a card, by the way, it could also be an app on your phone. 

Q. You outline a very ambitious roadmap for your pan-Nordic digital precision medicine initiative, with 2019 being the year in which a Nordic-wide solution for data portability and interoperability should become available, and 2020 being the year in which a fully established MyData health network is in place. What feedback have you received to this roadmap?

Many say that they are very happy with the condensed overview we provide on what we see as the main issues. Also, nobody really doubts that it makes sense to co-operate among the Nordic countries on the digital health revolution. But it will obviously be hard to get it through politically. All that we have talked about is not really prioritised on a ministerial level in any of the Nordic countries at the moment. There are precision medicine initiatives everywhere, but they don’t really connect to digital healthcare infrastructures. This is what we need the bottom-up movement for!  

Wrap-up

There is increasingly less doubt that PHRs, in one way or the other, will be at the centre of healthcare data integration in the future. Whether they will be the tools that physicians primarily work with, or whether they rather will evolve towards digital patient platforms that interconnect with the provider systems via – hopefully – international standards, remains to be seen. In any case, patient-centricity is a key feature of any PHR, and one in which there remains a lot of room for improvement in many existing solutions. With their MedMij project, the Dutch are trying to address this issue, and also the question of how a PHR ecosystem with independent products of independent providers can be established without sacrificing interoperability.

What we have also been learning recently is that a document-only PHR is nothing more than a first step. Not only do healthcare providers need structured data. Patients, too, must be able to contribute data, and they should be able to work with this data with the help of knowledge databases and artificial intelligence algorithms etc. This is where Bogi Eliasen is heading to with his far broader vision of a PHR that evolves from document storage towards becoming a platform for precision medicine. This is, by the way, also what the European Commission is trying to push ahead now with its vision of data-driven medicine that combines sophisticated PHRs with precision medicine tools. This is ambitious, to say the least, but certainly a vision worth working towards.

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