As mentioned in previous posts, the United4Health project was intended to test the deployment at scale of mobile health solutions and to integrate those telehealth services as part of the standard of care. Participants took this to heart and used the project to help tackle larger issues of policy, funding, technology, resources and overall workflow. The following interview explores some of these larger issues, specifically: the need to realign payment models, challenges around the adoption of communications and data standards, the role of test and certification bodies like Continua, overcoming systems integration challenges, patient generated data, and how sensors need to evolve for use in remote monitoring solutions. Europe strikes me as being ahead of the US in eHealth adoption and utilization, and in the following interview, Dr Fensli shares his rich experience earned through academic study and real life patient care via United4Health. I met Dr Fensli while working on the United4Health project, an EU telehealth project that endeavored to demonstrate large scale deployment of remote monitoring services for the management of three chronic conditions: congestive heart failure, chronic obstructive pulmonary disease and Diabetes Mellitus (Type II). Dr Fensli has a PhD in Biomedical Engineering focused on wireless ECG sensors, and is currently head of the research Centre for eHealth at University of Agder, Norway. Bridget Moorman: Tell me a bit about what is happening in Norway with regard to telehealth and your role in it. Dr Fensli: Typically, there are many R&D projects trying out new healthcare services, and most of them will struggle with the transition from ending a project to have sustainable services up running. Our experience is that the Norwegian health reform from 2012, the Coordination Reform, is shifting more responsibilities from specialist services (hospitals) to the primary care services which are at the local municipality (city) level in Norway. Unfortunately, the necessary money to provide the services has not followed the patients, and especially when it comes to new telemedicine solutions is anticipated to pose tremendous problems. In the United4Health project, we managed to establish in our region three new telemedicine centers as inter-municipality services to follow up the new point-of-care services with patients performing home-monitoring of vital signs measurements combined with a video consultation with a trained nurse. The operating expenses related to those centers increased costs for the municipalities, while at the same time anticipated reduction in hospital readmission showed savings for the hospital. In order to make such a shift in the services, we needed to establish a new health care business model in Norway. What is currently happening with telemedicine services in Norway is that the new Directorate of Ehealth (established from January 01, 2016) is taking the responsibilities for arranging five national pilot projects and that are supposed to be a model for future services. Additionally, a number of committees involving stakeholders from the municipalities are working on different aspects trying to come up with national frameworks and recommendations. Perhaps the most important strategy is to implement a new national electronic health record solution for all the 419 municipalities in Norway; however, this project is working on a 20-year perspective. Bridget Moorman: You have recently become involved in the Continua Health Alliance (now part of the Personal Connected Health Alliance) – what is it that you hope your membership and involvement will bring? Dr Fensli: We in Norway are very interested in the adoption of a standard for social care alarms* in addition to telehealth solutions, and hope that our involvement in Continua will help them move towards either the development or identification of standards for social care alarms. Additionally, we are interested in harvesting and integrating the health and wellness data that patients are personally gathering for their use and help in the delivery of their healthcare. At the last Paris Continua summit in June 2015, there was a lot of talk about integrating data from the health and wellness sector with data from the healthcare delivery sector and I am excited about that because if we can get the information from a FitBit device or some other sensors to the healthcare clinicians, then we could look at better long-term management of particular patients with chronic conditions. I believe that Continua can bring a plug-and-play reality to this integration such that it will be possible to implement. For example, right now the Fitbit data is in an open cloud and if we could get it into a secure cloud with some data privacy mechanisms, that would be ideal. I anticipate the development of a personal health diary or a “Healthbook” where the patients can collect their needed information and documentation of dedicated tasks for example when in a rehab phase where recordings of physical activities can be of importance. This information should easily be shared with physicians in a secured manner. Use of the Continua guidelines would allow us to ensure that security framework** as well as a possible easier route for data integration and interoperability. Bridget Moorman: You had also mentioned that your lab was building a demo that uses FHIR and IBM IIB (IBM Integration Bus). Can you explain what those are and why you are using them? Dr Fensli: FHIR is an HL7 standard for transfer or integration of medical data which is based on XML, and what is nice about it is that it makes the information in a message easy to implement using web services. Of course, in order to be truly interoperable you need the underlying standards for the messaging and data. IBM IIB is a service-oriented integration broker which allows information to flow between disparate applications using various protocols. We will also implement a secure authentication mechanism based on HTTPS, which meet Norway’s stringent security requirements. With regard to the underlying data standards, we are using the IBM IIB broker to manage that, so we can send sensor data from mobile systems into a secured framework and the IIB can receive data based in the FHIR format. Inside the secured framework, different subscribers can have access to the data, and if needed the IIB can convert it to the actual formats required by the end applications. In Norway, the Directorate of Ehealth has stated in a national reference design that data received from the patients should be stored in an XDS format. There will be a national XDS repository to store all data, and an XDS registry that will allow a flexible search mechanism for actual data based on metadata definitions. In our lab, we will establish a model for a regional XDS system to be integrated with the national registry, with the aim of having a realistic test infrastructure for verifying proper integration of new healthcare solutions and services. Our local R&D partner, Edge Consulting, is establishing the Norwegian Continua Test and Certification Centre, which allows for new ICT tools with devices and services to be implemented and properly tested. Bridget Moorman: When I speak with doctors about remote monitoring systems, I inevitably hear about their concern regarding being inundated with data, the quality of that data and based on that quality their duty to act on that data. Going back to your statement about wanting to have available the health and wellness data as well as the data gathered in the clinical setting for healthcare, do you not have some concern regarding the difference in data quality from those two different sensor systems? Dr Fensli: First remember that as healthcare evolves and if we are talking about chronic conditions, we are looking at helping the patient to self-manage their condition. This has been done with diabetes for years using glucometers and adjusting their insulin intake based on those measurements. Right now, for some of these chronic conditions, we have patients tracking themselves and then a nurse is calling them and talking with them about managing their condition, spending about 20 minutes a call. The nurse and the patient aren’t only relying on the absolute value of the data but are looking at the data trend over time. If the patient can be taught to correctly obtain the measurement and we can automate some of the trend analysis and educational material, we can optimize the clinician time to those patients where they truly need to intervene. As in the case of diabetes management, the patient may even be able to modify the doses of their medication. I think the future options in analyzing Big Data combined with individual profiles will give new possibilities to advise patients in treatment interventions, and flag a warning to the clinician in cases needed for manual interactions by the health care personnel. Bridget Moorman: I would agree that CHF and Diabetes (type II) are chronic conditions which have well established self-management protocols which use fairly simple remotely monitored physiological parameters (weight and HbA1C, respectively), however for management of COPD in the U4H project, pulse oximetry (SPO2) was used instead of spirometry due to spirometry’s extensive clinical involvement needed to gather clinically relevant data (good spirometric readings usually require significant coaching on the part of a clinician to ensure the patient expires as much air as possible from their lungs to obtain proper volume readings during the measurement). Even though SPO2 is an indirect and lagging measurement for COPD that can be fraught with false or inadequate readings due to the underlying design of pulse oximetry, the physiological proclivities of hemoglobin***, and sensor placement inadequacies, it was the best currently available remote monitoring technology for the system. As Norway was involved with the U4H study in the management of COPD, would you agree that the underlying clinical condition and the current technology for available remote monitoring devices may limit the efficacy of the remote monitoring system? Dr Fensli: In pure theoretical sense, yes, maybe there are limitations; however, we found that most of our patients had co-morbidities, i.e. that many of those with COPD also had Diabetes and CHF, so the use of a combined remote monitoring system would help those patients with all of their conditions. Moreover, in the COPD system, we also required that the patients answer a standardized questionnaire which gave us a more subjective set of data as their own observed symptoms, to combine with the vital signs data for a more holistic evaluation of the patient’s condition. In our eHelath Lab we used co-design methods to develop and implement the underlying system that allowed the data to be gathered, displayed and then analyzed by the clinicians. As a part of our research, my colleagues interviewed many patients who participated in the project, and they reported an increased feeling of safety as well as caring by the trained nurses at telemedicine center, and this was indeed important for them to be able to continue the treatment from their own home instead of being readmitted to the hospital. They also described how they now could self-evaluate their actual conditions based on training from reporting their actual symptoms in the questionnaire. I believe this is a strong indication of a positive contribution to increased empowerment. Hopefully, this can be improved for patients with multi-morbid conditions with future refinements of the developed system. Bridget Moorman: OK, so you are saying that since the human body is a complex integrated system itself, a possible deterioration in one of those conditions may also exacerbate or indicate indirectly a deterioration of another of their conditions. In addition, adding some qualitative data can give some depth to the albeit limited physiological data. Are you all following up on that? Dr Fensli: Yes, we have a study in which we are developing an integrated a telehealth system for these patients with co-morbidities and we are implementing it across southern Norway. This project is managed by the Sorlandet Hospital, and together with several of the municipalities in this region, we will try to expand the scope for patients with chronic conditions. It is in fact a complicated puzzle to have all the logistics and technical infrastructure implemented with a focus of sustainable services for the future. And still, the business model in health care services has to be changed. Bridget Moorman: I’d like to ask you about data standards. The Continua guidelines and the IHE profiles are built in a layered fashion starting out at the telecommunications layers and moving then to data and messaging layers. Telecommunication and application layers are areas that are of interest to all industries and so that consensus standards for interoperability will be resolved fairly quickly. Where the healthcare industry has the most influence is in demanding that data and messaging standards that benefit them are developed and adhered to, i.e., are specified and required for interfacing any of their applications. Frankly, I have not seen many healthcare organizations require adherence to data standards, when in fact, the data is what is important. What do you think of this? Dr Fensli: You are correct, specifying the data and messaging standards is where we have the influence, and yes, we should be concerned most about the data. As for specifying it in acquisition documents, you are correct. Here in Norway, we are working at a governmental level to ensure that certain data and messaging standards are specified for any systems or devices that are used or integrated to our healthcare systems. However, in addition to specifying a data standard, I want that data along with some context. For example, let’s say you have a pulse rate being measured. I’d like to know where it was measured, how it was measured, who it was measured on, etc. Once I have the physiological measurement data along with the information about the data (metadata), I can then ensure it is placed in the proper database “receptacle” on my end. Right now we rely on middleware/integration engines to provide that contextual information or metadata. Appending metadata to the physiological measurement parameter really belongs at the sensor level – as a smart sensor – and should be gathered at the same time and place as the sensor data. Most of the devices I use in remote monitoring today only send me the measured physiological parameter. If I can have a smart sensor that provides the physiological measurement and metadata, it can flow easily to any myriad of systems I have that would benefit from the data. Right now I need several brokers in between to append the metadata, translate the data, sort it and route it or in some cases, force me to use a point-to-point dedicated system to ensure the data is properly received and routed to the system or systems of interest. I think that is one thing that medical device vendors could work on in their device evolution and development strategies. So, I’d like to see the data standard also have a provision for the metadata and have my device or sensor gather that information at the point-of-measurement and send it along with the physiological measurement. In addition, smart sensors for the future will not only measure and send data, the smartness will allow us to implement reasoning functions into the sensor, being able to draw important conclusions before transmitting the data, and even decide when to transmit the data and include some priorities of emergency. A personal gateway as a smart-phone will also be able to directly give advice to the patient with functions like virtual personal coaching being available on 24/7/365 basis as a remote assistant for the doctors. Bridget Moorman: As stated up above, the purpose of U4H was to demonstrate the large scale deployment of a remote monitoring system for the management of chronic conditions. This was not supposed to be a ‘pilot’ project and the goal was to have the remote monitoring system be a part of the standard-of-care. What was the most difficult aspect of this project for you and how did you overcome it? Also, is remote monitoring now part of the standard of care? Dr. Fensli: As I have described we had to solve some technical issues mostly due to the strict regulations in Norway based on principles on privacy, and restrictions in shared access to medical information. But the most difficult and time-consuming tasks were tackled by the people responsible for how to integrate and implement new telemedicine services within existing health care organizational structures. We implemented changes in the patient pathway by introducing a new telemedicine service. At the same time, it was extremely difficult to change the way of giving actual treatment, and we had to follow existing time-consuming procedures for sending necessary information about a new patient to be included in the trials to all partners involved in the treatment procedures. In the final documentation from the U4H project, this is included as important information from our trial in South Norway as lessons learned. Establishing new sustainable services was indeed the most difficult challenge, and now we can continue in a follow-up research project and the broad deployment we obtained can be prolonged, hopefully being adopted when new healthcare business models are brought into reality in Norway. Bridget Moorman: Thank you, Dr Fensli and good luck with your follow-on project. * Social care alarms are alarms (GPS based and text enabled, sometimes two-way) in elderly peoples’ home to help with tracking (dementia, etc) – these are linked back through the municipal emergency response systems. ** Norway has some very strict laws regarding the co-mingling of any patient health data that is patient obtained versus obtained by a clinician. Additionally, they have strict data privacy laws which require fully encrypted pathways for all healthcare data transmission) – specific information regarding the technical details of their implementation can be found here: http://united4health.eu/wp-content/uploads/2015/10/D5.2-v1.0-U4H-Technical-documentation-and-recommendations.pdf as well as D5.7 when it is uploaded on the U4H site. *** Arterial blood gas measurement (ABG) would be the ‘gold standard’ but that currently requires a blood draw and lab analysis-of course once a ‘lab-on-a chip’ become widely available, the breadth of the use of remote monitoring for healthcare will most probably expand greatly. The next blog post will be about NHS24 in Scotland and their implementation of a portal supporting patients who have had falls using FHIR as part of the EU project SmartCare.