The use of monitoring techniques to collect patient data: A legal perspective

PICASO has had the advantage of having a legal expert from VUB as a project partner. In addition to sitting on the Ethical Board, VUB has advised the consortium on the applicable regulatory frameworks and legal requirements, both in the context of ‘PICASO as a research project’ and in the context of ‘PICASO as an exploitable system’. In particular, the consortium was advised on legal issues that related to surveillance issues and to the use of patient data in a manner that was foreseen by the PICASO project.

Moreover, the legal requirements in relation to data privacy and data protection as the General Data Protection Regulation (GDPR) came into force on 25 May 2018 (i.e. halfway into the project) were carefully analysed to ensure that the project complied. Finally, the potential issues that might arise as a result of Medical Device Regulation were also carefully considered and discussed within the project. A detailed analysis of the legal issues in the context of PICASO are provided in D3.5 Privacy Compliance Laws Associated with Surveillance.

To fully understand the legal framework and requirements related to PICASO, it was first of all necessary to conceptualise PICASO in two forms: i) ‘PICASO as an exploitable product’ which refers to a platform architecture that potentially will be deployed after the PICASO project has been finished and ii) ‘PICASO as an exploitable system’ which refers to the described trials in two different legal jurisdictions.

‘PICASO as an exploitable product’
The goal of the PICASO is to demonstrate that the federation of patient data is possible in a way that respects ethical and legal concerns surrounding privacy. The diagram bellow shows one possible way to view the architecture of the project.

This view of the architecture demonstrates some key features of a potential PICASO system that may be used. Some of the most important elements that are important from a legal perspective are: i) Patient data is not stored centrally in a cloud, ii) A number of physicians or carers may have access to a patient’s data, and iii) Individual patients will have control over which physicians can see their data and what they can see, and iiii) (iv) This can include data that comes from mobile monitoring devices.

‘PICASO as an exploitable system’
The aim of the PICASO project is to demonstrate the possibility of such an infrastructure (as described above) on a small scale in the context of two controlled trials in Germany and Italy. These trials will involve the communication of data between specialists of two different categories in other to demonstrate the principles discussed above. In both instances all data will be transferred between the local hospital site and other care providers through the use of a local cloud service provider. This provider will be based in the same jurisdiction as the trial is taking place. All processing will be in compliance with local data protection law and ethical requirements. This involved getting clearance from local ethics committees and producing consent forms for trial participants in line with both the demands of the local ethic committees and the demands made by the PICASO ethical board.

To find out more see D3.5 Privacy Compliance Laws Associated with Surveillance.

Surveillance, Stigma and Dignity

The ethics of surveillance raises a number of issues but in PICASO we have focused on stigmatisation and human dignity. Both issues are extremely important in the context of healthcare in general and with specific focus on the patient, notably a chronic patient, in particular. Surveillance, monitoring, stigmatisation and human dignity cannot be separated from a discussion on privacy and protection of personal data, especially as the digitalisation of societies, and of healthcare, increases and spreads.

Deliverable D3.4 Ethical Analysis of Monitoring and Privacy Impact Assessment carried out an ethical analysis of these issues. The analysis was placed in context of the PICASO home-monitoring solutions used by the patients in the two trials. Patients tested and used the home-monitoring solution:

1) to measure and monitor blood pressure, weight and activity (steps per day) using the provided devices and the PICASO App for transferring data to the clinic

2) to monitor well-being and medication adherence with the use of very short questionnaires that were answered directly in the PICASO Patient Dashboard.

The analysis will help the reader understand why it is important to consider the ethical aspects of using surveillance and monitoring technologies in a healthcare context and how the PICASO project has approached these issues. The concept of (human) dignity was also be analysed as it is central to our understanding of privacy and data protection and the threats to these in a digital age. There is a clear link between the analysis and the Ethical Guidelines and Principles in the project.

The deliverable D3.4 Ethical Analysis of Monitoring and Privacy Impact Assessment will be available for download in the “Knowledge Centre” menu after the project’s final review scheduled for August 2019.

The PICASO Ethical Guidelines

The PICASO Ethical Guidelines were based upon the project’s Ethical Principles. The guidelines were implemented in the project by means of the development of a check list, The PICASO Ethical Check List. The Check List is a tool for the project to check if the Ethical Principles were implemented and that applicable regulatory requirements were fulfilled.

The Check List was formatted as a series of questions aimed to ensure that the trials were conducted in an ethically sound manner with respect to the involvement of patients and their personal data. The Check List was used to assess compliance with the Ethical Guidelines as well as relevant data protection and privacy regulations. In fact, annual compliance and monitoring reports (internal reports) were completed which were largely based upon the results of completed Check Lists. Both trials have shown compliance with the Ethical Guidelines and the PICASO Ethical Board has also approved the annual compliance reports indicating that the PICASO project and in particular the two project trials have been conducted in an ethically sound manner.

The PICASO Ethical Guidelines and the Ethical Check List are available in D3.3 The PICASO Ethical Guidelines.

The PICASO Ethical Board

The PICASO Ethical Board was established as an advisory entity soon after the project started. The PICASO Ethical Board consists of the project’s Ethical Manager (Chair), a legal expert, the two trial owners (internal members) and three external expert members.

The PICASO Ethical Board had its first meeting on 25 May 2016 where the ethical issues relevant to the project and the two trials were discussed, the PICASO Ethical Guidelines and Principles were defined, and the board’s Terms of Reference were agreed upon.

Three annual Ethical Board meetings have been held during the project’s lifetime. The board meetings have been used to discuss the ethical concerns/challenges either foreseen or encountered and advise on the best resolution. The meetings were actually held prior to active involvement of patients in the trials and thus represented a good opportunity for ensuring that any ethical and/legal issues were resolved before the trials started.

In addition, one online meeting was held in February 2019; the main purpose here was to give a final update on the project’s trials and their results as the trials were in their last phase.

The external board members have been very engaged in the project and their comments, observations and suggestions have been helpful and are truly valued by the project. See D3.3 PICASO Ethical Guidelines for more information about the Ethical Board.

The PICASO Ethical Principles

One of the first activities of the PICASO project was to establish a set of ethical principles and guidelines for the project. This was highly prioritised by the project because the two project trials would involve real patients who would test and evaluate the PICASO solutions.

First of all, an initial analysis of the main ethical issues that were relevant for the project and in particular with respect to the involvement of patients in the trials was carried out. The analysis identified seven ethical issues that would need to be carefully considered and monitored during the project: Informed Consent; Autonomy; Dignity; Stigmatisation; Inclusion; Privacy and Data Protection; Clinical Incidental Findings. The list was by no means exclusive nor did it imply that other ethical issues would not be considered nor dealt with in the project. The issues should also not be seen as completely separated; they may be interlinked in various ways, as well as implicating other matters of an ethical nature. As these issues were considered the most relevant ethical issues, they are closely linked to the Ethical Principles.

Secondly, the Belmont Report was consulted as it represents a valuable reference for defining ethical principles for research involving human subjects. The Belmont Report was created in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research but it continues to be relevant.
As a result, four Ethical Principle were defined and implemented in the project:

  • Respect for Persons
  • Beneficence
  • Justice
  • Respect of Confidentiality and Privacy

In order to ensure that the consortium had a common understanding of the practical implications of the Ethical Principles, concrete examples of how the principles should be applied in the project were also described. The principles and their application were discussed with the PICASO Ethical Board prior to being finally agreed to by the consortium.

For more information on the project Ethical Principles please see deliverable D3.3 The PICASO Ethical Guidelines.

Presentation of PICASO at DGIM 2019

The abstract ‘PICASO – Die Plattform für eine verbesserte persönliche, koordinierte Betreuung chronisch Kranker’ will be presented at the DGIM by Heinrich-Heine-University Düsseldorf, University Clinic Düsseldorf. The poster presentation is part of the theme, Digital Medicine, which will be presented on Monday 6th May.
The DGIM Congress takes place on 4-7 May 2019 at the RheinMain Congress Center in Wiesbaden, Germany.

PICASO at the XIV Congresso Nazionale AIMN 2019

Agostino Chiaravalloti from University of Rome “Tor Vergata” Hospital will present PICASO at the AIMN congress in Rimini, Italy, on 12 April 2019. This year, participants at the AIMN congress will earn Continuing Medical Education (CME) credits and is therefore very exciting to be able to present PICASO in this context. Moreover, audiences will be presented with a questionnaire on PICASO, allowing us to gather a unique insight into how PICASO is received by a wide professional audience.

Project Videos

Two different project videos are currently being produced by a professional film production company, MasterMedia. The film crew was recently in Rome to film interviews with professionals and patients on their experiences with using PICASO for the sharing of care plans and patient data. The video will demonstrate how PICASO helps to overcome the fragmentation of today’s health care systems by providing a data platform that ensures that all relevant information will reach patients and professional caregivers across care sectors on time.

The other project video will be an animation video that will demonstrate the PICASO home-monitoring solution from the patient perspective and how it supports patient adherence to the care plan. The video will demonstrate the PICASO tools that ensures an active inclusion of the patient as well as an easy way to communicate with other healthcare professionals based on safe data transfer.

Webinar: The PICASO Innovative Solutions for Integrated Care

The PICASO project is in its final stages with only three more months to go and we are eager to share the accomplishments of the project. We would therefore like to invite you to join us at our interactive webcast: The PICASO Innovative Solutions for Integrated Care

Update: The webcast is now available in the archive.

This first of two webcasts will be aired live on 26th March 2019 at 10:00CET.

To follow the webcast click here.

In this link you can also see the agenda and speaker profiles, the slides they present and you can pose questions to the speakers by filling in the feedback form. After that date you can access and see the archived version here: https://in-jet.public-i.tv/core/portal/home.

In this post you can read more about the PICASO results that will be presented and discussed at the webcast. We hope that you will join us on the 26 March.

Agenda Tuesday 26 March 2019, 10:00-11:30CET

Meeting Subject: The PICASO Innovative Solutions for Integrated Care
Venue: Webinar broadcast from Fraunhofer FIT, Sankt Augustin, Germany
Date: Tuesday 26 March 2019 @ 10:00CET

 

Time

Webinar:

The PICASO Innovative Solutions for Integrated Care

10:00 Welcome to the PICASO Project

           by Carlos A. Velasco, Project Coordinator, Fraunhofer FIT

Webinar presentations introduced and moderated by Jesper Thestrup, In-JeT ApS

10:05 PICASO Technical Overview and Architecture

            by Peter Rosengren, CNet Svenska

The PICASO platform enables sharing of a patient’s complete care pathways with tools to establish health status, predict risks and adjust care. By monitoring physiological parameters at home, patients can actively participate in their own care. The result is better management of co-existing diseases and coordination of care plans across organisations.

Q&A session
10:20 The FHIR Platform as an Interoperability Basis – Clinician Dashboard Overview

            by Carlos A. Velasco, Fraunhofer FIT

PICASO provides a HL7 FHIR (Fast Healthcare Interoperability Resources), enabled integration platform for sharing a patient’s complete care pathways across multi-actor care spaces. A Clinician Dashboard provides an integrated user interface to the main clinical functions and tools.

Q&A session
10:35 Web-based Technologies Employed in Integrated Data Visualisation

            by Jan Hreno, Technical University of Kosice

A Data Resource Browser and a Patient Data Viewer are provided to the care professionals to enable intuitive and quick search and browsing of patient data in distributed data repositories.

Q&A session
10:45 The PICASO Risk Manager and DIVA

             by Armanas Povilionis, Fondazione Universitaria Inuit Tor Vergata

The risk manager provides patient specific risk estimates at a clinician’s fingertips. Risk scores from standard risk charts as well as novel risk scores that use machine learning to fuse data from an entire patient’s history into a single integrated risk score in one single tool. A Distributed Validation Authority (DIVA) ensures that data are only shared if all policies and transaction specific privacy and security requirements are met.

Q&A session
11:00 Patient Dashboard

            by Matts Ahlsen, CNet Svenska

PICASO implements a number of services to allow for patients to be able to self-manage their diseases and monitor different vital signs under the supervision of formal as well as informal carers. This includes software for connecting home monitoring devices, accessing external cloud services and a Patient Dashboard for visualising vital signs and provide a diary for activities.

Q&A session
11:15 Summary and final comments
11:30 End of webinar

Presentation Abstracts

The following five topics will be presented at the workshop that will be webcasted live on 26 March 2019.

PICASO technical overview and architecture
Presented by Peter Rosengreen, CNet Svenska AB

The PICASO integration platform is built on a federation of multiple external and internal cloud solutions in order to match the needs of future care provision, while still respecting the legacy structure of today’s health care systems. The platform consists of three major cloud subsystems:

  • Multiple legacy care information systems, each operating as a private cloud or cloud-like internal business structure with strict access control and limited access rights, including secure storage of patient data. The PICASO care management system (for creating care plans) is located inside the secure private cloud due to the need for accessing multiple critical data repositories
  • The PICASO integration platform operating as a public cloud solution and providing the central integration service platform, such as management of secure data exchange between the multi-disciplinary actors, secure data collections from patients’ homes, and secure execution of care plan services
  • Multiple patient and environment monitoring systems running in the patients’ homes. Each of them exposes cloud web services and are thus regarded as the patient’s ‘private cloud’.

The FHIR platform as an interoperability basis. Clinician Dashboard overview
Presented by Dr Carlos A Velasco, Fraunhofer Institute for Applied Information Technology FIT

This presentation will describe how we use the HL7®/FHIR®© standard to leverage our platform by enabling interoperability across distributed data sources coming from different health institutions and service providers. The project has developed the Reference Data Server (RDS), which is built upon a scalable NoSQL database that supports data clustering. The Reference Data Server offers a standard REST interface (also based upon the FHIR specification), supporting the extensibility of the functionality for different target groups.

Within PICASO it is used to store standard and customised code systems and value sets, medications, and templates that support the creation of services for patient care plans.  The Clinician Dashboard is part of the PICASO Integrated Care Platform, providing a tool for sharing patients’ care plans across multi-actor care spaces from different institutions and service providers. The platform dynamically adjusts the content and management of the delivered care services, to ensure that they are always adapted to the patient’s personal health status and ability.

Web based technologies employed in integrated data visualisation (Data Resource Browser, Patient Data Viewer)
Presented by Jan Hreno, The Technical University of Kosice

Several aspects of clinical data browsing were considered for combining available visualisation technologies to present information to a clinical professional. The requirement for a quick overview is met by presenting an interactive mind map-like structure with the patient in the centre and providing the latest available observation values as nodes related to the patient. Tables, charts and timelines are then used to further investigate available data in detail, including historical data if available. Different time-specific data can be also compared on one common timeline, if needed. The developed visualisation tools provide plenty of features that support clinical professionals, creating an overview of the health status of patients with comorbidities, thus explicitly recognising possible conflicts in the treatment plan

The PICASO Risk Manager and DIVA
Presented by Armanas Povilionis, Fondazione Inuit Tor Vergata

The Risk Manager provides patient-specific risk estimates at the clinician’s fingertips. A selection of risk scores from standard risk charts as well as novel risk scores that use machine learning to fuse data from the entire patient history into a single integrated risk score  are deployed in one single tool. This includes the effect of co-morbidities as well as genetic, social and behavioural data. Such an integrated simulation tool allows the clinicians to explore with their patients what lifestyle changes will have the strongest impact on improving outcomes.

DIVA (DIstributed Validation Authority) ensures that data is only shared if all policies and transaction-specific privacy and security requirements are met. DIVA is combination of three components: Access Manager, Identity Manager and Policy Manager which ensures the following:

  • A secure connection to the PICASO Public Cloud and secure communication between Public and Local Clouds
  • That all actors are identified and authenticated while accessing PICASO services and that access to data is gained only if all necessary requirements are met
  • That data transactions are valid and compliant with pre-defined consent policy rules

Patient Dashboard
Presented by Matts Ahlsen, CNet Svenska AB

Measuring and monitoring of physiological parameters at home have clinical benefits and positive effects on the quality of life for chronic patients, because patients can play a more active role in their own care. The PICASO patient solution entails an easy-to-use dashboard where patients can measure important physiological parameters and monitor their health status for increased knowledge, a better overview and more control. The main functions include:

  • Care plan diary with schedules for medication intake
  • List of health measurements to do
  • List of clinical appointments
  • Integration of multiple care plans for easy overview and adherence
  • Sharing of monitored data with relevant stakeholders based on informed consent.

We hope that you will join us on 26th March 2019 at 10:00CET.

The PICASO Innovative Solutions for Integrated Care

Invitation

The PICASO project invites you to join this webinar where you will see innovative ICT solutions for care plan interoperability across care organisations, technologies for browsing for and visualising clinical data located across the care spectrum as well as risk management and patient interaction for remote monitoring.

Participants – who should attend?

This webinar is intended for Software Architects, Design Team Leaders, Project Engineers and Development Managers involved in software planning and development for integrated healthcare solutions. It is also intended for clinical users, physicians, healthcare authorities wanted to get acquainted with the newest technologies for care management.

All the listed speakers and other participants of the PICASO project as well as invited researchers from Fraunhofer FIT will be physical present in the webinar room during recording.

After each session, the speakers will take questions and discuss short topics with the audience.

Information and directions for how to watch the webinar

The webinar will be broadcasted live and from the archive via the internet and can be seen in a standard browser-based player. All common players are supported and no special plugins are needed.

The player will show the video and sound from the meeting, the name of the speaker, the slides presented and the topic discussed. Contextual information in the form of relevant documents and links are also presented.

During the live webinar streaming, the viewers will be able to pose questions to the speakers directly in the webinar player. The moderator will read the questions as they arrive.

Both live and archived versions of the webinar will be available here: https://in-jet.public-i.tv/

The live webinar will be available on 26 March at 10:00 CET. The archived version will be available from the same site until December 31, 2019. The entire webcast can be downloaded from the archive.

The physical venue will be at the Fraunhofer Institute for Applied Information Technology, Schloss Birlinghoven, 53757 Sankt Augustin, Germany.

Information on the speakers

Information of the speakers is found in the webcast when you click on the speaker name.

Organisers

The webinar is organised by the PICASO project, a research project funded under the EU H2020 Framework for Research and Innovation.

You can contact the organisers in the following way:

  • Questions about the project and the content: Carlos A. Velasco – carlos.velasco@fit.fraunhofer.de
  • Questions about the webinar form: Jesper Thestrup – webmaster@public-i.dk
  • General information about the project: www.picaso-project.eu

Copyright and acknowledgements

All copyrights for this presentation are owned in full by the PICASO Project.

Permission is granted to print material published in this presentation for personal use only. Its use for any other purpose, and in particular its commercial use or distribution, is strictly forbidden in the absence of prior written approval. PICASO has received funding from the European Union’s Horizon 2020 Framework Programme for Research and Innovation under Grant Agreement No 689209. Possible inaccuracies of information are under the responsibility of the project. This presentation reflects solely the views of its authors. The European Commission is not liable for any use that may be made of the information contained therein.

Workshop: Models for management of multi-morbidity

UDUS will host and run a workshop for professionals (clinicians, IT, and others) to present and discuss how PICASO can contribute to a harmonisation of treatment plans for patients with multiple co-morbidities. The PICASO solution to optimise the management of multiple treatment plans will also be presented and discussed and participants will learn first-hand about the first results from the trial run by UDUS.

The workshop takes place on 6 February 2019 from 15:00-18:00 at UDUS. The workshop will be conducted in German. If you are interested in participating please contact: picaso@rheumanet.org

Agenda:

Time Topic Speaker
15:00-16:00 Introduction to PICASO background

Demonstration of the platform

UDUS & consortium partner
16:00-16:30 Presentation of the first results UDUS
Coffee break
17:00-18:00 Discussion – How does PICASO contribute to harmonization of treatment plans and how can the management be further optimized?