Development Process for Type 2 Diabetes Patient Applications: Findings from a Literature Review.

For type 2 diabetes (T2D) patients, self-management of the disease is an essential part of the treatment. Patient portals and personal health records (PHRs) are powerful applications for self-managing T2D. It is however unclear what features of existing applications provide best support for self-management of type 2 diabetes. We retrieved and analyzed twenty-two studies to identify features which promote self-management of T2D. The results elicited 10 different features and showed that use of patient portals was associated with different health outcomes. Secure messaging, Viewing laboratory results, and Accessing medication history were the most common features, and some specific features were associated with health outcomes. In general, patient portals and PHRs were associated with improved health outcomes. Finally, nine overall recommendations for the development process of patient portals were identified.

Enhancing Women's Health: An Assessment of Data Privacy and Security of Menopause FemTech Applications.

Menopausal women increasingly rely on FemTech apps to manage their symptoms, as mobile applications can provide a convenient and easily accessible health solution. However, this scoping review and content analysis of 14 menopause apps available on Google Play in the European Union found that most applications categorisation is not aligning with their features as well as lack adequate data privacy and security sufficiency. Thereby sensitive health data of menopausal women are put at risk, highlighting the need for collaborative efforts between developers and regulators to implement effective and achievable data protection practices to enhance menopausal women's data safely.

Cyber Hygiene Methodology for Raising Cybersecurity and Data Privacy Awareness in Health Care Organizations: Concept Study.

BACKGROUND: Cyber threats are increasing across all business sectors, with health care being a prominent domain. In response to the ever-increasing threats, health care organizations (HOs) are enhancing the technical measures with the use of cybersecurity controls and other advanced solutions for further protection. Despite the need for technical controls, humans are evidently the weakest link in the cybersecurity posture of HOs. This suggests that addressing the human aspects of cybersecurity is a key step toward managing cyber-physical risks. In practice, HOs are required to apply general cybersecurity and data privacy guidelines that focus on human factors. However, there is limited literature on the methodologies and procedures that can assist in successfully mapping these guidelines to specific controls (interventions), including awareness activities and training programs, with a measurable impact on personnel. To this end, tools and structured methodologies for assisting higher management in selecting the minimum number of required controls that will be most effective on the health care workforce are highly desirable. OBJECTIVE: This study aimed to introduce a cyber hygiene (CH) methodology that uses a unique survey-based risk assessment approach for raising the cybersecurity and data privacy awareness of different employee groups in HOs. The main objective was to identify the most effective strategy for managing cybersecurity and data privacy risks and recommend targeted human-centric controls that are tailored to organization-specific needs. METHODS: The CH methodology relied on a cross-sectional, exploratory survey study followed by a proposed risk-based survey data analysis approach. First, survey data were collected from 4 different employee groups across 3 European HOs, covering 7 categories of cybersecurity and data privacy risks. Next, survey data were transcribed and fitted into a proposed risk-based approach matrix that translated risk levels to strategies for managing the risks. RESULTS: A list of human-centric controls and implementation levels was created. These controls were associated with risk categories, mapped to risk strategies for managing the risks related to all employee groups. Our mapping empowered the computation and subsequent recommendation of subsets of human-centric controls to implement the identified strategy for managing the overall risk of the HOs. An indicative example demonstrated the application of the CH methodology in a simple scenario. Finally, by applying the CH methodology in the health care sector, we obtained results in the form of risk markings; identified strategies to manage the risks; and recommended controls for each of the 3 HOs, each employee group, and each risk category. CONCLUSIONS: The proposed CH methodology improves the CH perception and behavior of personnel in the health care sector and provides risk strategies together with a list of recommended human-centric controls for managing a wide range of cybersecurity and data privacy risks related to health care employees.

Building an Ontology for Traditional Medicine by Comparing Traditional Medicine Information of Chapter 26 of ICD-11 with SNOMED CT.

Chapter 26 of the 11th revision of the International Classification of Diseases (ICD-11-CH26) has introduced Traditional Medicine knowledge for use and integration with Western Medicine. Traditional Medicine is the use of beliefs, theories, and experiences to provide healing and care. The amount of information on Traditional Medicine in Systematized Nomenclature of Medicine - Clinical Terms (SCT), the world's most comprehensive health terminology, is unclear. The purpose of this study is to address this unclarity and investigate to which extent the concepts of ICD-11-CH26 can be found in SCT. If a concept from ICD-11-CH26 has a corresponding, or similar, concept in SCT, the hierarchical structure of the concepts has been compared. Then, an ontology of Traditional Chinese Medicine using the concepts of SCT will be developed.

What Makes a Quality Health App-Developing a Global Research-Based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: Delphi Study.

BACKGROUND: The lack of an international standard for assessing and communicating health app quality and the lack of consensus about what makes a high-quality health app negatively affect the uptake of such apps. At the request of the European Commission, the international Standard Development Organizations (SDOs), European Committee for Standardization, International Organization for Standardization, and International Electrotechnical Commission have joined forces to develop a technical specification (TS) for assessing the quality and reliability of health and wellness apps. OBJECTIVE: This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality. METHODS: A 2-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42, 51%) or both (n=41, 49%) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the maximum 100 requirement questions for the uptake of apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries that participated in the SDO technical committees were invited to comment on 4 working drafts and subsequently vote on the TS. RESULTS: The final quality assessment framework includes 81 questions, 67 (83%) of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as "Healthy and safe," "Easy to use," "Secure data," and "Robust build." The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2-4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs, including 6 of the 10 most populous countries worldwide. CONCLUSIONS: A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers enhance and efficiently demonstrate the quality of health apps, consumers, and health care professionals to make informed decisions on health apps. It will also help insurers to make reimbursement decisions on health apps.

Influence of Human Factors on Cyber Security within Healthcare Organisations: A Systematic Review.

Background: Cybersecurity is increasingly becoming a prominent concern among healthcare providers in adopting digital technologies for improving the quality of care delivered to patients. The recent reports on cyber attacks, such as ransomware and WannaCry, have brought to life the destructive nature of such attacks upon healthcare. In complement to cyberattacks, which have been targeted against the vulnerabilities of information technology (IT) infrastructures, a new form of cyber attack aims to exploit human vulnerabilities; such attacks are categorised as social engineering attacks. Following an increase in the frequency and ingenuity of attacks launched against hospitals and clinical environments with the intention of causing service disruption, there is a strong need to study the level of awareness programmes and training activities offered to the staff by healthcare organisations. Objective: The objective of this systematic review is to identify commonly encountered factors that cybersecurity postures of a healthcare organisation, resulting from the ignorance of cyber threat to healthcare. The systematic review aims to consolidate the current literature being reported upon human behaviour resulting in security gaps that mitigate the cyber defence strategy adopted by healthcare organisations. Additionally, the paper also reviews the organisational risk assessment methodology implemented and the policies being adopted to strengthen cybersecurity. Methods: The topic of cybersecurity within healthcare and the clinical environment has attracted the interest of several researchers, resulting in a broad range of literature. The inclusion criteria for the articles in the review stem from the scope of the five research questions identified. To this end, we conducted seven search queries across three repositories, namely (i) PubMed®/MED-LINE; (ii) Cumulative Index to Nursing and Allied Health Literature (CINAHL); and (iii) Web of Science (WoS), using key words related to cybersecurity awareness, training, organisation risk assessment methodologies, policies and recommendations adopted as counter measures within health care. These were restricted to around the last 12 years. Results: A total of 70 articles were selected to be included in the review, which addresses the complexity of cybersecurity measures adopted within the healthcare and clinical environments. The articles included in the review highlight the evolving nature of cybersecurity threats stemming from exploiting IT infrastructures to more advanced attacks launched with the intent of exploiting human vulnerability. A steady increase in the literature on the threat of phishing attacks evidences the growing threat of social engineering attacks. As a countermeasure, through the review, we identified articles that provide methodologies resulting from case studies to promote cybersecurity awareness among stakeholders. The articles included highlight the need to adopt cyber hygiene practices among healthcare professionals while accessing social media platforms, which forms an ideal test bed for the attackers to gain insight into the life of healthcare professionals. Additionally, the review also includes articles that present strategies adopted by healthcare organisations in countering the impact of social engineering attacks. The evaluation of the cybersecurity risk assessment of an organisation is another key area of study reported in the literature that recommends the organisation of European and international standards in countering social engineering attacks. Lastly, the review includes articles reporting on national case studies with an overview of the economic and societal impact of service disruptions encountered due to cyberattacks. Discussion: One of the limitations of the review is the subjective ranking of the authors associated to the relevance of literature to each of the research questions identified. We also acknowledge the limited amount of literature that focuses on human factors of cybersecurity in health care in general; therefore, the search queries were formulated using well-established cybersecurity related topics categorised according to the threats, risk assessment and organisational strategies reported in the literature.

Can the European EHR Exchange Format Support Shared Decision Making and Citizen-Driven Health Science?

The European Commission published in 2019 the Recommendation on the European Electronic Health Record exchange format (EHRxF) to support citizens and healthcare providers in securely accessing and sharing EHRs. The European EHRxF is expected to contribute to the digital transformation of health and care in the digital single market empowering citizens and building a healthier society. This paper presents areas of work that need to be resolved for the European EHRxF to advance shared decision-making for patients and citizen-centered science.

Designing internet-enabled patient education for self-management of T2D diabetes-The case of the Razavi-Khorasan province in Iran.

BACKGROUND: The number of people with diabetes is estimated to increase to 642 million by 2040, with most having type 2 diabetes. Patients with diabetes require continuous monitoring and possible treatment changes. Patient education is the process of enabling individuals to make informed decisions about their personal health-related behaviours and internet-enabled interventions have the potential to provide support and information to patients with diabetes. OBJECTIVE: The aim of the study was to design a portal prototype based onto two models of care and a contextualised education programme to support the self-management of diabetes patients by involving stakeholders in the Iranian province of Razavi-Khorasan. METHODS: A Design-Based Research framework was adopted. A qualitative research method was used to analyse interviews with patients and care givers. Mock-ups were developed first and designed with features of user-driven and self-care models of care. The mock-ups also had adaptation features, such as for control of the disease, ability to cure self, and family support. The portal prototype was developed iteratively by building on the mock-ups and evaluated through interviews. The features and elements of the mock-ups and the portal prototype were evaluated in an outpatient diabetes clinic in Mashhad. RESULTS: Thirty-three participants were involved in the study. The evaluation of the mock-ups resulted in two themes and seven categories: 1) self-care improvement, including self-care requirements and self-management, and 2) educational usefulness, including medical information, information mode, mobility, interaction, and efficiency. The mock-up evaluation was used as a basis for designing a portal prototype. Next, the portal prototype was evaluated, and three categories emerged from the interview data: 1) user experience, 2) functionality, and 3) interactivity. Participants were not able to prioritise between the two care models. Some functionalities of the portal could benefit from the development within a cultural context to determine differences to the best way to present material. CONCLUSIONS: A portal prototype has been designed to include two care models to support self-management and functionalities that support aspects of culture-specific diabetes self-care. This study provides guidance on developing an internet-enabled educational portal, aimed at providing support for patients in their social context.

Towards an Ontology for Trustful mHealth Apps.

A unified and integrated approach to represent mHealth apps and their characteristics is currently lacking. To fill this gap, the overall purpose of this project is to develop an ontology, to help address the objective of building 'trustful' mHealth apps. This paper is a brief presentation of the followed methods, and the preliminary results of the research, i.e. a first version of that ontology.

Linked Open Data in the Biomedical Information Area: A Keywords Analysis.

The objective of this paper was to determine the extent of the usage of "Linked Open Data" within biomedical literature. Applying PRISMA statement for literature reviews, forty-six papers were included in the analysis and keywords identified. Keywords have been classified according to MeSH categories, when possible. Twenty-three keywords had a frequency > one, 146 keywords had a frequency equal to one. Two MeSH categories were recurring. Future work includes applying association rules learning to keywords.

User-Centric eHealth Tool to Address the Psychosocial Effects of Sickle Cell Disease.

Sickle cell disease (SCD) is the most prevalent blood inherited disorder in the world. Patients suffer from several chronic issues, comorbidities and high-mortality rates. Despite its prevalence, the disease remains largely ignored. A literature review was conducted and a questionnaire was sent to patients in order to understand the potential of e-health tools to support people with SCD. Additionally, focus groups have been conducted to detail respondents' answers. The results showed that patients felt isolated and misunderstood. They also highlighted patients' wishes for a social network able to make them feel less scattered. Using participatory-design techniques, we designed a prototype of user-centric interface for an online self-supportive SCD patient community. The mock-ups include chatrooms, forums and videoconferences capabilities. They illustrate how SCD patients' social networking and caregivers-patient relationship needs could be met. Future work will focus on the implementation and evaluation of the system.

Domains of Health IT and Tailoring of Evaluation: Practicing Process Modeling for Multi-Stakeholder Benefits.

This contribution focuses on the heterogeneity and complexity of health information technology services and systems in a multi-stakeholder environment. We propose the perspective of process modeling as a method to break out complexity, represent heterogeneity, and provide tailored evaluation and optimization of health IT systems and services. Two case studies are presented to show how process modeling is needed to fully understand the information flow, thus identifying requirements and specifications for information system re-engineering and interoperability; detect process weaknesses thus designing corrective measures; define metrics as a mean to evaluate and ensure system quality; and optimize the use of resources.

A Design Methodology for Medical Processes.

BACKGROUND: Healthcare processes, especially those belonging to the clinical domain, are acknowledged as complex and characterized by the dynamic nature of the diagnosis, the variability of the decisions made by experts driven by their experiences, the local constraints, the patient's needs, the uncertainty of the patient's response, and the indeterminacy of patient's compliance to treatment. Also, the multiple actors involved in patient's care need clear and transparent communication to ensure care coordination. OBJECTIVES: In this paper, we propose a methodology to model healthcare processes in order to break out complexity and provide transparency. METHODS: The model is grounded on a set of requirements that make the healthcare domain unique with respect to other knowledge domains. The modeling methodology is based on three main phases: the study of the environmental context, the conceptual modeling, and the logical modeling. RESULTS: The proposed methodology was validated by applying it to the case study of the rehabilitation process of stroke patients in the specific setting of a specialized rehabilitation center. The resulting model was used to define the specifications of a software artifact for the digital administration and collection of assessment tests that was also implemented. CONCLUSIONS: Despite being only an example, our case study showed the ability of process modeling to answer the actual needs in healthcare practices. Independently from the medical domain in which the modeling effort is done, the proposed methodology is useful to create high-quality models, and to detect and take into account relevant and tricky situations that can occur during process execution.

Advising patients on selecting trustful apps for diabetes self-care.

BACKGROUND: There has been a dramatic increase in mobile apps for diabetes self-care. However, their quality is not guaranteed and patients do not have the appropriate tools for careful evaluation. OBJECTIVE: This work aims to propose a tool to help patients with diabetes select an appropriate app for self-care. METHODS: After identifying the conceptual framework of diabetes self-care, we searched Apple US app store and reviewed diabetes self-care apps, considering both generic and diabetes-specific features. Based on an existing tool for representing the benefits and weaknesses of medical apps, we created the pictorial identification schema/Diabetes Self-care tool, which specifically identified medical apps in the diabetes domain. RESULTS: Of the 952 apps retrieved, 67 were for diabetes self-care, while 26 were excluded because they were not updated in the last 12 months. Of the remaining 41, none cost more than 15 USD, and 36 implemented manual data entry. Basic features (data logging, data representation, and data delivery) were implemented in almost all apps, whereas advanced features (e.g., insulin calculator) were implemented in a small percentage of apps. The pictorial identification schema for diabetes was completed by one patient and one software developer for 13 apps. Both users highlighted weaknesses related to the functionalities offered and to their interface, but the patient focused on usability, whereas the software developer focused on technical implementation. CONCLUSIONS: The Pictorial Identification Schema/Diabetes Self-care is a promising graphical tool for perceiving the weaknesses and benefits of a diabetes self-care app that includes multiple user profile perspectives.

Design and development of an AAC app based on a speech-to-symbol technology.

The purpose of this paper is to present the design and the development of an Augmentative and Alternative Communication app that uses a speech to symbol technology to model language, i.e. to recognize the speech and display the text or the graphic content related to it. Our app is intended to be adopted by communication partners who want to engage in interventions focused on improving communication skills. Our app has the goal of translating simple speech sentences in a set of symbols that are understandable by children with complex communication needs. We moderated a focus group among six AAC communication partners. Then, we developed a prototype. We are currently starting testing our app in an AAC Centre in Milan, Italy.

A connecting system for cardiological lexicons.

The purpose of this paper is to present the approach and the development of a software application ("lexicons connecting" system) to correlate effectively and unambiguously the correspondence between the specialist medical vocabulary and the familiar medical vocabulary for the cardiovascular domain. To investigate the question, the idea, the design, and the implementation of such system will be described. To this end, firstly, a number of research methodologies will be examined including domain ontologies development, database design and implementation. Then, the following implementation methodology and its results are presented. Finally, an example of the application use will be depicted and future work will be briefly described.

Implementing the lifelong personal health record in a regionalised health information system: the case of Lombardy, Italy.

BACKGROUND: The use of personal health records (PHRs) can help people make better health decisions and improves the quality of care by allowing access to and use of the information needed to communicate effectively with others concerning their health care. OBJECTIVE: This work presents the lifelong PHR system of the Lombardy region as an example of the implementation of an e-health solution that is capable of providing personal clinical documents from a lifelong perspective, integrating different healthcare providers over a large territory. METHODS: The lifelong PHR is embedded in the regional healthcare information system of Lombardy, which is characterised by a large and heterogeneous territory, a large number of different healthcare providers and organisations, and a significant population. RESULTS: The lifelong PHR makes clinical documents available to healthcare professionals and citizens when needed, and it is automatically updated with all of the documents regarding a clinical event regardless of which healthcare provider is currently taking care of the patient. Present statistics show that the lifelong PHR has experienced a wide diffusion in a short period of time, and at the end of 2010, it was active for more than five million Lombardy citizens. Digital reports and e-prescription transactions have almost doubled since 2007 and have reached a coverage of almost 100%. CONCLUSIONS: The qualified and exhaustive collection of patient clinical data and documents should impact daily medical practice, as well as the care pathways and services provided to patients, and should help in the renewal of health assistance and the simplification of patients' access to care.

Towards a decision support system for hand dermatology.

The complexity of the medical diagnosis is faced by practitioners relying mainly on their experiences. This can be acquired during daily practices and on-the-job training. Given the complexity and extensiveness of the subject, supporting tools that include knowledge extracted by highly specialized practitioners can be valuable. In the present work, a Decision Support System (DSS) for hand dermatology was developed based on data coming from a Visit Report Form (VRF). Using a Bayesian approach and factors significance difference over the population average for the case, we demonstrated the potentiality of creating an enhanced VRF that include a diagnoses distribution probability based on the DSS rules applied for the specific patient situation.

Modeling stroke rehabilitation processes using the Unified Modeling Language (UML).

In organising and providing rehabilitation procedures for stroke patients, the usual need for many refinements makes it inappropriate to attempt rigid standardisation, but greater detail is required concerning workflow. The aim of this study was to build a model of the post-stroke rehabilitation process. The model, implemented in the Unified Modeling Language, was grounded on international guidelines and refined following the clinical pathway adopted at local level by a specialized rehabilitation centre. The model describes the organisation of the rehabilitation delivery and it facilitates the monitoring of recovery during the process. Indeed, a system software was developed and tested to support clinicians in the digital administration of clinical scales. The model flexibility assures easy updating after process evolution.

Challenges of the e-Health curricular education in bio-medical engineering and in medicine.

Curricular recommendations coming from highly respectable associations are highly useful. Nevertheless, they show fatigue in keeping the pace of any fast evolution, as in the ICT happens. So we do the attempt to disclose the emerging challenges affecting e-Health curricular education.