Consent Management System on Patient-Generated Health Data.

We consent to many things in life, but sometimes we do not know what we consent to. When discussing data protection in Europe, consent has been associated with permission under the GDPR, and health data are highly sensitive. Patients cannot make an informed decision without being provided with the information they need upfront: no informed decision, no informed consent. This paper presents a consent management system for patient-generated health data stored with HL7 FHIR specification, tested on Type 1 diabetes synthetic data. This architecture, based on using FHIR as an unequivocal data exchange format, can lead to individuals (patients) taking control of their data, enabling potential data exchange and reuse of health data across countries and organisations, in line with the European Commission proposal of a European Health Data Space.

Privacy Concerns Related to Data Sharing for European Diabetes Devices.

BACKGROUND: Individuals with diabetes rely on medical equipment (eg, continuous glucose monitoring (CGM), hybrid closed-loop systems) and mobile applications to manage their condition, providing valuable data to health care providers. Data sharing from this equipment is regulated via Terms of Service (ToS) and Privacy Policy documents. The introduction of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Union has established updated rules for medical devices, including software. OBJECTIVE: This study examines how data sharing is regulated by the ToS and Privacy Policy documents of approved diabetes medical equipment and associated software. It focuses on the equipment approved by the Norwegian Regional Health Authorities. METHODS: A document analysis was conducted on the ToS and Privacy Policy documents of diabetes medical equipment and software applications approved in Norway. RESULTS: The analysis identified 11 medical equipment and 12 software applications used for diabetes data transfer and analysis in Norway. Only 3 medical equipment (OmniPod Dash, Accu-Chek Insight, and Accu-Chek Solo) were registered in the European Database on Medical Devices (EUDAMED) database, whereas none of their respective software applications were registered. Compliance with General Data Protection Regulation (GDPR) security requirements varied, with some software relying on adequacy decisions (8/12), whereas others did not (4/12). CONCLUSIONS: The study highlights the dominance of non-European Economic Area (EEA) companies in medical device technology development. It also identifies the lack of registration for medical equipment and software in the EUDAMED database, which is currently not mandatory. These findings underscore the need for further attention to ensure regulatory compliance and improve data-sharing practices in the context of diabetes management.

Information and communication technology-based interventions for chronic diseases consultation: Scoping review.

BACKGROUND: Medical consultations are often critical meetings between patients and health personnel to provide treatment, health-management advice, and exchange of information, especially for people living with chronic diseases. The adoption of patient-operated Information and Communication Technologies (ICTs) allows the patients to actively participate in their consultation and treatment. The consultation can be divided into three different phases: before, during, and after the meeting. The difference is identified by the activities in preparation (before), the meeting, conducted either physically or in other forms of non-face-to-face interaction (during), and the follow-up activities after the meeting (after). Consultations can be supported by various ICT-based interventions, often referred to as eHealth, mHealth, telehealth, or telemedicine. Nevertheless, the use of ICTs in healthcare settings is often accompanied by security and privacy challenges due to the sensitive nature of health information and the regulatory requirements associated with storing and processing sensitive information. OBJECTIVE: This scoping review aims to map the existing knowledge and identify gaps in research about ICT-based interventions for chronic diseases consultations. The review objective is guided by three research questions: (1) which ICTs are used by people with chronic diseases, health personnel, and others before, during, and after consultations; (2) which type of information is managed by these ICTs; and (3) how are security and privacy issues addressed? METHODS: We performed a literature search in ACM, IEEE, PubMed, Scopus, and Web of Science and included primary studies published between January 2015 and June 2020 that used ICT before, during, and/or after a consultation for chronic diseases. This review presents and discusses the findings from the included publications structured around the three research questions. RESULTS: Twenty-four studies met the inclusion criteria. Only five studies reported the use of ICTs in all three phases: before, during, and after consultations. The main ICTs identified were smartphone applications, web-based portals, cloud-based infrastructures, and electronic health record systems. Different devices like sensors and wearable devices were used in 23 studies to gather diverse information. Regarding the type of information managed by these ICTs, we identified nine categories: physiological data, treatment information, medical history, consultation media like images or videos, laboratory results, reminders, lifestyle parameters, symptoms, and patient identification. Security issues were addressed in 20 studies, while only eight of the included studies addressed privacy issues. CONCLUSIONS: This scoping review highlights the potential for a new model of consultation for patients with chronic diseases. Furthermore, it emphasizes the possibilities for consultations besides physical and remote meetings. The scoping review also revealed a narrow focus on security and privacy. Security issues were more likely to be mentioned in the included publications, although with limited details. Future research should focus more on security and privacy due to the increasing amount of sensitive information gathered and used for consultations.

Criteria for Assessing and Recommending Digital Diabetes Tools: A Delphi Study.

Diabetes self-management, an integral part of diabetes care, can be improved with the help of digital self-management tools such as apps, sensors, websites, and social media. The study objective was to reach a consensus on the criteria required to assess and recommend digital diabetes self-management tools targeting those with diabetes in Norway. Healthcare professionals working with diabetes care from all health regions in Norway were recruited to participate in a three-round Delphi study. In all rounds, the panellists rated criteria identified in a systematic review and interviews on a scale from 0-10, with the option to provide comments. On a scale of 0:not important to 10:extremely important, the highest rated criteria for assessing and recommending digital diabetes self-management tools were "Usability" and "Information quality", respectively. For assessing apps, "Security and privacy" was one of the lowest rated criteria. Having access to a list of criteria for assessing and recommending digital self-management tools can help diabetes care stakeholders to make informed choices in recommending and choosing suitable apps, websites, and social media for self-management. Future work on quality assessment of digital health tools should place emphasis on security and privacy compliance, to enable diabetes care stakeholders focus on other relevant criteria to recommend or choose and use such tools.

Methods and Evaluation Criteria for Apps and Digital Interventions for Diabetes Self-Management: Systematic Review.

BACKGROUND: There is growing evidence that apps and digital interventions have a positive impact on diabetes self-management. Standard self-management for patients with diabetes could therefore be supplemented by apps and digital interventions to increase patients' skills. Several initiatives, models, and frameworks suggest how health apps and digital interventions could be evaluated, but there are few standards for this. And although there are many methods for evaluating apps and digital interventions, a more specific approach might be needed for assessing digital diabetes self-management interventions. OBJECTIVE: This review aims to identify which methods and criteria are used to evaluate apps and digital interventions for diabetes self-management, and to describe how patients were involved in these evaluations. METHODS: We searched CINAHL, EMBASE, MEDLINE, and Web of Science for articles published from 2015 that referred to the evaluation of apps and digital interventions for diabetes self-management and involved patients in the evaluation. We then conducted a narrative qualitative synthesis of the findings, structured around the included studies' quality, methods of evaluation, and evaluation criteria. RESULTS: Of 1681 articles identified, 31 fulfilled the inclusion criteria. A total of 7 articles were considered of high confidence in the evidence. Apps were the most commonly used platform for diabetes self-management (18/31, 58%), and type 2 diabetes (T2D) was the targeted health condition most studies focused on (12/31, 38%). Questionnaires, interviews, and user-group meetings were the most common methods of evaluation. Furthermore, the most evaluated criteria for apps and digital diabetes self-management interventions were cognitive impact, clinical impact, and usability. Feasibility and security and privacy were not evaluated by studies considered of high confidence in the evidence. CONCLUSIONS: There were few studies with high confidence in the evidence that involved patients in the evaluation of apps and digital interventions for diabetes self-management. Additional evaluation criteria, such as sustainability and interoperability, should be focused on more in future studies to provide a better understanding of the effects and potential of apps and digital interventions for diabetes self-management.

The House of Carbs: Personalized Carbohydrate Dispenser for People with Diabetes.

Patients with diabetes are often worried about having low blood glucose because of the unpleasant feeling and possible dangerous situations this can lead to. This can make patients consume more carbohydrates than necessary. Ad-hoc carbohydrate estimation and dosing by the patients can be unreliable and may produce unwanted periods of high blood glucose. In this paper we present a system that automatically estimates and dispenses the amount of juice (or similar) according to the current patients' blood glucose values. The system is remotely accessible and customizable from a chatbot, exploits sensors and actuators to dispense the necessary amount of liquid carbohydrates. It relies on a cloud solution (Nightscout) to acquire the patient's blood glucose values, which are constantly updated thanks to a commercial wearable continuous glucose monitor (CGM).

Measuring the Effects of Sharing Mobile Health Data During Diabetes Consultations: Protocol for a Mixed Method Study.

BACKGROUND: There is rising demand for health care's limited resources. Mobile health (mHealth) could be a solution, especially for those with chronic illnesses such as diabetes. mHealth can increases patients' options to self-manage their health, improving their health knowledge, engagement, and capacity to contribute to their own care decisions. However, there are few solutions for sharing and presenting patients' mHealth data with health care providers (HCPs) in a mutually understandable way, which limits the potential of shared decision making. OBJECTIVE: Through a six-month mixed method feasibility study in Norway, we aim to explore the impacts that a system for sharing patient-gathered data from mHealth devices has on patients and HCPs during diabetes consultations. METHODS: Patients with diabetes will be recruited through their HCPs. Participants will use the Diabetes Diary mobile phone app to register and review diabetes self-management data and share these data during diabetes consultations using the FullFlow data-sharing system. The primary outcome is the feasibility of the system, which includes HCP impressions and expectations (prestudy survey), usability (System Usability Scale), functionalities used and data shared during consultations, and study-end focus group meetings. Secondary outcomes include a change in the therapeutic relationship, patient empowerment and wellness, health parameters (HbA1c and blood pressure), and the patients' own app-registered health measures (blood glucose, medication, physical activity, diet, and weight). We will compare measures taken at baseline and at six months, as well as data continuously gathered from the app. Analysis will aim to explain which measures have changed and how and why they have changed during the intervention. RESULTS: The Full Flow project is funded for 2016 to 2020 by the Research Council of Norway (number 247974/O70). We approached 14 general practitioner clinics (expecting to recruit 1-2 general practitioners per clinic) and two hospitals (expecting to recruit 2-3 nurses per hospital). By recruiting through the HCPs, we expect to recruit 74 patients with type 2 and 33 patients with type 1 diabetes. Between November 2018 and July 2019, we recruited eight patients and 15 HCPs. During 2020, we aim to analyze and publish the results of the collected data from our patient and HCP participants. CONCLUSIONS: We expect to better understand what is needed to be able to share data. This includes potential benefits that sharing patient-gathered data during consultations will have on patients and HCPs, both individually and together. By measuring these impacts, we will be able to present the possibilities and challenges related to a system for sharing mHealth data for future interventions and practice. Results will also demonstrate what needs to be done to make this collaboration between HCPs and patients successful and subsequently further improve patients' health and engagement in their care.