PICASO will deploy a home-monitoring solution where the involved patients will be asked to use and test at least three different devices to monitor specific health parameters. The devices used in the project have been carefully selected to ensure that they fulfill the necessary security and quality requirements in order to protect patients, and clinicians, in the trials from harm.
Paul Quinn, representing the project’s legal expert partner, VUB, has published an article in Computer Law & Security Review that discusses the regulation of mHealth devices in the context of the EU Medical Device Framework (MDF) and the how the concept “intended purpose” is used to determine if a device or mobile app have to comply with the MDF. The article entitled “The EU commission’s risky choice for a non-risk based strategy on assessment of medical devices” questions if this key concept is really adequate to protect patient safety.
Article abstract
Regulation of medical devices has been one of the most notable regulatory initiatives of the European Union. The need to ensure that medical devices are of a high quality is self-evident in nature. This is demonstrated by the lack of willingness of both healthcare institutions and professionals to use medical devices that have not properly been certified. In determining which devices are medical devices and should therefore meet the requirements of the regulatory framework, both the current and the proposed frameworks foresee a central place for the concept of ‘intended purpose’. This means that only those manufacturers that have explicitly stated that their device is to be used for a medical purpose should have to comply with the medical device framework. Unfortunately, however, this concept has become increasingly problematic given the rise in mHealth (mobile health) practices and ‘appification’ (shift to mobile devices) in particular, arguably posing potentially serious risks to human health in certain cases. This article discusses the problems that are created by the ever-increasing amount of ‘well-being’ apps and the fact that most will not be classed as medical devices. Despite apparently being aware of these problems, the EU Commission has opted to maintain its current approach in the newly proposed regulation, choosing not to employ other approaches as the FDA has for example done in opting to use a ‘risk based case-by-case approach’.
The Computer Law and Security Review (CLSR) is an international journal of technology law and practice providing a major platform for publication of high quality research, policy and legal analysis within the field of IT law and computer security. The article is available online at www.sciencedirect.com.
To Dorthe Stief Christensen, coordination of treatment and acknowledgement of patient input are key elements in the design of a better care for people who live with multiple chronic diseases.
Dorthe Stief Christensen is 50 years old and works as Social Consultant at the Danish Association of the Physical Disabled
When Dorthe Stief Christensen was 4, she was diagnosed with juvenile idiopathic arthritis, a systemic kind affecting not only her joints but also her organs and which made her suffer from high fever and infections for long periods of time. Then, during adulthood, other conditions emerged; she started having urinary tract infections and blood infections and in 2006, at 39 she experienced heart problems and was brought into hospital to have her heart arteries widened.
Dorthe has always been convinced that her kidney and heart conditions were somehow related to her arthritis and the medication she took, however, she has struggled to make the health system acknowledge the connections and look at her from a holistic point of view.
– When I was diagnosed as a child, there was no talk about the future risks of other possible diseases or implications. My arthritis was treated separate from everything else and as I grew up and confronted my rheumatologists with the possible relationship between my arthritis and medication on one hand and my urinary tract infections, blood poisoning and later my heart problems on the other, they refuted the claims by saying there was no clinical evidence, Dorthe recalls.
As a consequence, new, unknown symptoms resulting from the co-occurrence and interaction of diseases and medication were not acknowledged.
– I have experienced situations where doctors ignored the serious symptoms that I had and did not react on the fact that multi-diagnosis or medication can add unknown symptoms to the single diagnose, she says.
Today, the connections between her arthritis and heart problems are scientifically proven, however, treatment is still not coordinated. Dorthe has seen many different and highly skilled doctors from rheumatologists, cardiologists, nephrologists, urologists to surgeons who have looked at and treated her conditions in insolation but who have never worked together even though she often tried to invite them to communicate. The lack of a holistic viewpoint, Dorthe believes is due to the culture and structure of the healthcare system which favours a silo-oriented approach.
– Doctors are used to working in silos where they specialise in one certain area and build their opinions based on the scientific evidence within this field of expertise. No one seems to speak the same language or take an overall, holistic position, leaving this part wholly to the patient, who in turn risks being ignored when trying to draw the whole picture, she says.
Dorthe acknowledges that she is responsible for her own health and care but then, she argues, her input must also be accepted as an equally important part of the treatment.
– After a whole life with a chronic disease, you know the reactions of your body very well and this should be taken seriously by the doctors, she argues.
Who should be the coordinator?
According to Dorthe, the patient should not solely carry the coordination burden, since it is a strenuous task for the patient who often feels left alone and because it also bears the risk of losing crucial knowledge.
– I always have to remember what to say when I am at one specialist, and what to say at another. So, every time I am having DEXA scanning of my bones in relation to my arthritis, I have to make them aware of my artificial hips. And when having an intravenous drip inserted at hospital, I have to remind the personnel to fetch an anesthetic doctor to do it since my veins are very sensitive and difficult. I have to remember that a certain type of antibiotics damages my kidneys and that I cannot have NSAID’s [Non-Steroidal Anti-Inflammatory Drugs] for the arthritis because of my heart problems. If all this information was available beforehand and pointed out clearly, I would not need to remember everything and especially in cases of emergency where I might not be able to provide such important information, common knowledge about me would save precious time and provide better care. Today, only information about allergies is registered and shared explicitly in the health system, she explains.
Dorthe also points out the benefit of efficiency from better coordination;
– If doctors had access to each other’s examinations, they and I would not have to start from scratch every time. If they could share more information about me, I would not have to do things double like today, when I have to go down twice for blood samples because it is for different doctors, even though they use the same readings – “now why could they not all have access to one blood sample?”, Dorthe wonders.
However, when it comes to who should coordinate treatment and medication, the answer is not as straightforward;
– My own doctor [General Practitioner – GP] is an option but I don’t use him much being a patient in the specialised world. My rheumatologists have followed me from my childhood and would be my obvious choice but they do not see it as their role to do this. Also, when I ask why they do not take my blood pressure as a preventive action, considering the relationship between some anti-inflammatory drugs and risk of heart problems, they say that the GP should do this, she says.
A more personalised, dynamic health system
The way forward according to Dorthe is to create a more dynamic and personalised health system based on sharing more relevant information than is done today as well as designing care to be more flexible.
– It would be great if a common care plan could be made based on a system where there is access to more relevant data such a
s blood samples and possible drug interactions and to design a system that provides pop-up messages with notifications on what to be aware of in dealing with this individual patient. Also, the care plan should be flexible enough to counter for immediate needs, and not be bound on fixed consultation times and rigid contact procedures, she argues.
Today, Danish patients can log in and access information about their consultations and test results via a health portal, however, it is only final results that are shown and not partial results. In Dorthe’s case this means that she cannot see the x-rays leading up to the conclusion by the rheumatologist but only the conclusion itself. In her opinion, the patient can only be empowered if all results are visible, and if the patient can add information.
– Patients hold crucial information which should not only be listened to, but registered and passed on for the benefit of knowledge sharing. The patient should be able to add information in the system by writing comments about own experiences. In the case of several patients experiencing the same conditions or symptoms, these patterns could be detected and investigated sooner, rather than too late, she argues.
I do not google
Today Dorthe’s arthritis is not in an active state, meaning that there is no clinical sign of inflammation. She has to take medication for her heart and lives with a reduced kidney function due to chronic cystitis as well as endometriosis, which is, like her arthritis, an autoimmune disease. In many ways, Dorthe has become an expert in her own health, however, she prefers not to focus too much on her conditions but rather on leading a healthy life.
– I do not get too involved or google illnesses or symptoms but focus on exercise, necessary rest, proper food and dietary supplements and I have confidence in my doctors providing answers if there is something I am unsure about. Nevertheless, when I choose to participate in this interview it is because I want to emphasise the importance of coordination in our health system and a system which is customisable according to people’s individual needs and not vice versa, she concludes.
Want to know more about the PICASO scenarios, use cases, architecture and data models? Or are you more into ethics and communication? Then visit our recent deliverables which are now open to the public.
You can find the download page here and get an overview of all our public deliverables here. If you are interested in more knowledge coming from PICASO, then visit our knowledge centre which is continously updated with new material.
Analysis of the care plan management, guidelines and handover procedures in the two clinical partner institutions has resulted in a set of recommendations for the PICASO platform.
The PICASO platform is integrating data from the various healthcare professionals that a patient is in contact with to support the sharing of data across these sectors and obtain coordinated care plans, tailored to the need of the individual patients. Trial sites are the University Hospital of Tor Vergata in Rome and the University Hospital of Düsseldorf who have started identifying where and how the PICASO system can be evaluated in the two clinical trials, involving patient groups with Parkinson’s disease and Rheumatoid Arthritis.
During initial discussions, the following recommendations for PICASO functionalities surfaced covering data capture, visualisation and exchange:
PICASO shall aim at supporting the caring physicians to follow the various available guidelines by providing data that are prerequisites for the fulfilment of the guidelines and that are rarely always collected by the specialist alone;
Alerts and events are highlighted in the graphical user interface when entering the PICASO platform so that the healthcare professional becomes aware of new entries;
Automatic check of available data for risk assessment issues as well as a list of what data are missing before risk assessment can be completed;
Risks are made available to all relevant, accredited healthcare professionals so care is taken for the patient in whatever setting she is in. The new data generated would then be available in the next step to others, and thus allow timely decision support;
Visualisation of patient data from the various sources should be readily accessible for the clinician and easy to digest during appointments;
Data exchange should happen electronically instead of being paper-based.
In addition, the Italian trial stresses the importance of giving informal carers, such as relatives, access to relevant information including medication plans, clinical appointments and home monitoring data since in Italy, the relatives play a central role in the care of the older generation.
The recommendations have resulted in a range of requirements which are continuously processed, considering the aims of the project.
Patient empowerment and protection
To protect the rights of the patients in the trials, informed consent from the participating patients is acquired to exchange their data among healthcare professionals and to enable them and/or their informal carers to visit the PICASO platform regularly and see their data.
The increased knowledge and visibility of one’s own data and health status are central steps towards empowering the patient, making him or her more involved in the decisions;
– The patient should be able to have control over his or her personal data, determining who has access to what information and when. However, the patient also needs to know the implications; if data are not available due to the patient restricting the sharing of data, certain guidelines and care plan recommendations cannot be fulfilled, explains Senior Consultant, Trine Sørensen from In-JeT ApS, who is Ethical Manager in PICASO.
PICASO follows standard ethical principles as well as current legislation when dealing with real patients. An ethical board has been appointed to ensure that the PICASO project trials are executed in an ethically sound manner and in accordance with relevant national and international ethical and legal requirements for trials involving real patients.
– The ethical guidelines in PICASO are based on the main principles of respect, beneficence, justice, confidentiality and privacy which all project partners have committed to honour, says Trine Sørensen.
Two trials will demonstrate and evaluate the PICASO platform: In Germany, the Policlinic of Rheumatology and Hiller Research Unit Rheumatology at the University Hospital of Düsseldorf and in Italy, the University Hospital of Tor Vergata in Rome.
The two trials represent different national settings and different patient groups: The University Hospital of Düsseldorf engages patients diagnosed with Rheumatoid Arthritis whereas Tor Vergata enrolls patients with Parkinson’s disease. However, both patient groups have Cardio Vascular Diseases as comorbidities, thus sharing the complexity of treating co-occurring diseases.
The overall purpose of the trials is to demonstrate the PICASO platform and its components as a platform, enabling collaborative sharing of patient information for a more holistic view of patients with comorbidities. The trials will also validate the PICASO impact on the effectiveness of the care systems and the degree of acceptance from the wider group of stakeholders, patients, and relatives. Apart from these common traits, there are noteworthy differences between the two settings.
Trial 1: Patients with Rheumatoid Arthritis
The trial at the University Hospital of Düsseldorf (UDUS) will involve a total of 30 patients over 18 years of age with Rheumatoid Arthritis (RA) and Cardiovascular Disease as comorbidity. The trial is divided into two time periods of nine months with 15 patients participating in each period.
Treatment of RA is driven by a multidisciplinary approach and involves different experts, e.g. rheumatologists, ergo-/physiotherapists, orthopedics, general practitioners, and dermatologists. The patients are managed in terms of medication, physiotherapy, exercise and health status with the main aim of achieving/retaining a permanent good remission status of the inflammatory rheumatic disease. However, a strong focus is also on the comorbidities that the patients have;
– In Rheumatology, despite a good control of the inflammatory rheumatic disease reflected by a permanent good remission status, the consequent management of comorbidities has come to the fore and is recommended by e.g. the European League against Rheumatism. However, rheumatologists and other specialists usually lack the necessary data which are not available at the point of care. PICASO aims at filling this gap, explains PD Dr. Jutta Richter from the Policlinic of Rheumatology and Hiller Research Unit at the University Hospital of Düsseldorf.
The aim of the trial is thus to support a collaborative sharing of care plans between the relevant actors for a more holistic view of the patient;
– Sharing information about the patient provides the caring physicians with the opportunity to care not only for one disease but have a much more complete picture of the patient and all of his comorbidities and treatment plans. Having access to for example recent cardiology examinations, will also make it possible to avoid redundant examinations and associated costs, says Jutta Richter.
More information = new concerns?
The patients in the trial will be able to document and become more informed about their own health status by having home monitoring equipment installed, measuring blood pressure, weight and activity. They will also be asked to assess their physical well-being at the beginning of the trial and again at the end.
At first thought, the increase in information is beneficial for all stakeholders since it offers better insight into the health status and enables the patient to take proper action. However, at second thought, it also bears the risk of generating new concerns:
– Although it is usually regarded as useful for the caring stakeholders to have a more complete picture of the patients and all their comorbidities and treatment plans, this opportunity might also lead to multi-faceted, varying resistances and concerns of the involved stakeholders. The trials will allow for an assessment of this issue and the results will be presented as part of the evaluation of the trials, concludes Jutta Richter.
Target outcomes for UDUS
The primary outcomes that the trial at the University Hospital in Düsseldorf target are:
User acceptance, adaptability and usability factors from the perspective of the patients and physicians;
Secure and accurate handling of data and data sharing in PICASO;
Improved outcome e.g. health and quality of life;
Active participation by patients and their informal carers in the care process and management;
Reduced number and length of admissions to hospital.
The secondary target outcomes are:
Increased medical knowledge on the provision and better management of integrated care for patients with multiple comorbidities;
More efficient, dynamic and personalised care;
More efficient sharing of relevant data and care plans between the involved physicians and other stakeholders as social carers.
At UDUS, recruitment is planned to start early 2017 after which the first nine-month trial will launch.
Trial 2: Patients with Parkinson’s disease
The trial at Tor Vergata (UTV) will involve patients over the age of 65 with Parkinson Disease (PD) and Cardiovascular Disease as comorbidity. 30 patients will be recruited of which ten patients will be selected to test PICASO and twenty will be part of a control group. The highest incidence of PD is detected in patients over 65 years of age and cardiovascular disease, diabetes and kidney failure are among the most frequent comorbidities.
A significant amount of data is usually generated for this patient group due the complexity of diseases, and data are difficult to manage since data are handled in paper and delivered in person by patients with the risk of irrelevant or missing test results;
– The management of the complex patient generates a considerable amount of data that are difficult to manage and data are often are delivered in person by the patient during visits. This involves a burden of responsibility for both the patient and carers. On top of this, the specialist must use significant resources to handle the large amount of data, leaving less time for the patient. The trial will test the effect of using PICASO for better management of data, says Dr. Agostino Chiaravalloti from the University Hospital of Tor Vergata.
Analysing the effect of home monitoring
The patients involved in the trial will be able to measure blood pressure, heart rate, drug intake, medication reminders, sleep and activity at home so that they and their carers can view their health data.
The trial is unique as it is designed as a multi-site and multi-hospital case matched control trial (before-and- after PICASO system) of chronically ill patients affected by Parkinson’s Disease living in their own homes, which has never previously been attempted in Italy. The results will therefore be used to analyse the deployment of telehealth services across Italy;
– The aim is to provide clinical and health economic evidence on how Telehealth services can be scaled up nationally to provide an alternative cost effective health service for the management of chronic disease in the community, explains Dr. Agostino Chiaravalloti.
Integrating formal and informal carers
Since patient data are exchanged between two independent hospitals in the Italian trial, it will be possible to test the concept of integrating formal carers across institutions and discover potential issues affecting the scalability of the PICASO solution. Special attention will also be paid to the integration of informal carers e.g. family which take on a critical role in caring for the elderly patients in Italy and in more general in the Mediterranean;
– There will be a strong focus on the involvement of informal carers to provide insight on how their close integration affects issues such as patient empowerment, autonomy and privacy. Also, we will specifically analyse the usability and impact of the PICASO solution on the older generation, since we deal exclusively with patients over the age of 65, says Dr. Agostino Chiaravalloti.
Target outcomes for UTV
Tor Vergata has identified the following primary target outcomes:
Inform unclear/equivocal treatment decisions;
Determine the efficacy of therapy and supporting appropriate adjustments;
Support the appropriate adjustments of drug therapy for patients who have previously misdiagnosed or over-treated;
Promote medication adherence (compliance) and lifestyle changes and to make patients more aware of their condition;
Evaluate control of clinical parameters in patients discharged home from hospital with newly commenced or altered therapy.
The secondary target outcomes are:
Usability both valued by patients and doctors;
Integration in the management of care;
Improved participation of patients and their informal carers.
UTV has started recruiting patients for PICASO and will start their trial in April 2017.
Workshops and interviews with clinicians, carers and patients have been conducted to elicit initial user requirements for the PICASO system.
To fully understand the challenges and possibilities for improving the ways information and data are generated, stored and shared among stakeholders, a first step in PICASO has been to identify current patient pathways, clinical use cases and clinical workflows of the two trial sites. This includes the kind of patient data that are generated, how and when data are shared, and between whom in the two trial sites.
Through workshops and interviews, clinical partners, carers and patients have helped map current practices and suggestions as to where practices could be optimised and supported by PICASO. These recordings have been developed into vision scenarios and To-Be use cases, describing activities and application functionalities from which technical requirements can be withdrawn.
Using the system
To gain a better understanding of user interaction with PICASO services, vision scenarios have been created, using personas. The vision scenarios describe a mainstream story of a patient being referred from one physician to another for diagnosis, treatment or (physio-)therapy.
PICASO’s role in support of this process for all stakeholders involved is described in detail, particularly when it pertains to an integrated care approach. The scenarios describe how different stakeholders can access and share relevant patient data via the PICASO platform based on their roles and associated access rights. They illustrate how the PICASO platform enables cross-management of documentation and care plans, and that the patients can be enrolled in a remote monitoring scheme and be supported in keeping track of their daily treatment schedule e.g., for medication adherence.
Improving the procedures
Another method used is the development of To-Be use cases from current practice. Handover procedures and data exchange between clinicians and between clinician and patients and/or informal carers are mapped to identify possible improvements in the procedures enabled by the PICASO system. Additional To-Be use cases offer new ways to collect patient data such as from remote patient monitoring to assist clinical care.
The To-Be use cases describe the envisioned PICASO enabled solutions for optimising the existing clinical workflows in the two trials and for data handling and sharing between different specialists and between specialist and patients and, if applicable, their informal carers.
Specific user and technical requirements are elicited from the To-Be use cases and fed into the development of the technical architecture of the PICASO platform. Refining and adding requirements will take place continuously and in conjunction with the design of the system.
Better coordination of care plans between healthcare sectors is high on the European health agenda. So is
efficient management of the steadily rising number of patients with co-existing chronic conditions. The
PICASO project aims to develop information and communication technologies which meet these demands,
by supporting a continuum of care from hospitals and outpatient clinic to the home:
– The PICASO platform will enable the sharing of a patient’s complete care pathways with tools to
establish health status, predict risks and adjust care. Based on monitoring of different physiological
parameters at home, the patients can actively participate in their own care. The result is better
management of co-existing diseases and coordination of care plans for the benefit of patients and
carers across organisations, explains Project Coordinator, Dr. Markus Eisenhauer from Fraunhofer
Institute for Applied Information Technology.
Trials in Italy and Germany
To demonstrate the platform and its wide applicability, the technologies will be trialled in two different
national settings with two different patient groups, counting up to a 100 patients: in Italy, the University
Hospital of Tor Vergata in Rome will enrol patients with Parkinson’s disease and in Germany, the University
Hospital of Düsseldorf will engage patients diagnosed with Rheumatoid Arthritis. Both patient groups have
Cardiovascular Diseases as co-morbidities and both settings share the complexity of treating co-occurring
diseases:
– Clinical treatment of people with co-morbidities is much more complex than treatment of patients
with a single condition since treating one chronic condition can have negative effects on another.
The treatment is also very individual and patients have to work closely with doctors and therapists to
establish a suitable patient programme, accommodating the patient’s particular and changing needs.
PICASO can support the management of these programmes which involves different disciplines,
multiple care channels and actors, explains Dr. Agostino Chiaravalloti from the University Hospital of
Tor Vergata.
His view is backed up by PD Dr. Jutta Richter from the Policlinic of Rheumatology and Hiller Research Unit
at the University Hospital of Düsseldorf who concludes:
– The trials will establish how PICASO can improve the exchange of data between stakeholders in the
workflow and validate the effect of PICASO on the care systems as well as the acceptance of the
system by the wider group of stakeholders such as patients, relatives and the society at large.
According to Dorthe, the patient should not solely carry the coordination burden, since it is a strenuous task for the patient who often feels left alone and because it also bears the risk of losing crucial knowledge.
The way forward according to Dorthe is to create a more dynamic and personalised health system based on sharing more relevant information than is done today as well as designing care to be more flexible.