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.

Identification of Medicinal Products: Providing an Educational Framework.

The ISO standards for the Identification of Medicinal Products (IDMP) prove to be difficult to implement. Guidance needs to be provided to those using and further developing IDMP-related standards and terminologies. Providing fitting and structured education would be a step forward. This article describes research of current education and certification on IDMP and the creation of an educational framework for targeted IDMP knowledge transfer. This framework indicates the required level of knowledge for the various identified roles within the organizations working with IDMP. Based on a combination of desk research, a questionnaire, and individual interviews, relevant roles were identified covering the various organizations (Users, Educators, Medicine Authorities, Standard Developing Organizations, and IT-suppliers) and five levels of required knowledge were determined, including applicable roles and educational components. Furthermore, this article lists several recommendations that should be taken into consideration whilst developing content and implementing educational modules for IDMP.

Social connectedness through ICT and the influence on wellbeing: the case of the CareRabbit.

The CareRabbit has been introduced as a technological innovation in the care for children, enabling family and friends to stay in touch while the child is hospitalized. This study addresses influence of this innovation on the wellbeing of the children, and uses the validated KINDL questionnaire, eliciting information from children and parents at the end of hospitalization. A baseline and an experimental measurement are compared. The children in the CareRabbit group scored slightly higher on the KINDL questionnaire than children in the control group. For young children (age 4-7) the difference was large. Initial findings indicate that CareRabbit has a positive influence on wellbeing, although sample size and measured differences limit the support for this conclusion. The measured difference suggests that CareRabbit may be more valuable for younger children.

Medintel: decision support for general practitioners: a case study.

Short consultations and a large and growing amount of available medical information make searching for suitable information difficult for general practitioners. Thus information is often not searched for or not found, diminishing the quality of care. We propose a system that offers decision support by combining medical information sources with data from the electronic patient record. A first evaluation shows that a system like Medintel can be a useful supportive tool and can increase the quality of care provided by general practitioners.

HL7's comprehensive standards set and its international collaboration for enabling semantically interoperable eHealth and pHealth solutions.

The workshop is organized by HL7 and its affiliates to present and to discuss HL7's activities for providing international standards and specifications to enable advanced semantically interoperable eHealth and pHealth solutions, adaptable to national health systems through localization. The workshop especially focuses on the multi-disciplinary structure of HL7 and its liaisons with international and national standards developing organizations as well as important health informatics initiatives. Demonstrating existing and emerging solutions and strategies within HL7's broad scope and spectrum, the international scope of HL7 standards is highlighted.

IPS Governance Framework: Current Practices in Specification Use and Updates.

The eStandards methodology stressed the importance of trust and flow for health data as a key characteristic of well-functioning health systems. A digital health compass, leveraging perspectives of health systems, digital health markets, citizens, and workforce, drives a process of co-creation, governance and alignment in eStandards. A repository of best practices and common components further advances interoperability, as new projects add their experience. This paper proposes a governance framework for requirements management, intelligence gathering, specification use, and updates to promote sustainable governance for International Patient Summaries. It is based on interviews of 14 patient summary projects and initiatives in Europe and the United States.

In Search of a Digital Health Compass to Navigate the Health System.

Healthcare systems increasingly rely on digital technologies to sustain costs and improve access to quality care. Data drive a wave of automation aspiring to improve productivity by forging connections between health and wellness, medical research, and clinical decision support. Mobile apps and patient-generated data combined with provider recordings pave the way towards personalized care pathways and just-in time access to health services. Navigating the health ecosystem becomes challenging as roles and relationships change. This paper reflects on the digital health compass to navigate the health system using one's own data. Health information technology standards are at the core of the compass, to tap the potential of shared aggregate data and sustain trust. The notion of the patient summary as a window to one's health is used as an example to drive our call for action for health informatics to develop methods to calibrate the digital health compass and feed on 'my data', respecting 'my decision', to fuel 'our ePower'.