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.publishedVersionPeer reviewe

The Medical Imaging Interaction Toolkit (MITK) – a toolkit facilitating the creation of interactive software by extending VTK and ITK

The aim of the Medical Imaging Interaction Toolkit (MITK) is to facilitate the creation of clinically usable image-based software. Clinically usable software for image-guided procedures and image analysis require a high degree of interaction to verify and, if necessary, correct results from (semi-)automatic algorithms. MITK is a class library basing on and extending the Insight Toolkit (ITK) and the Visualization Toolkit (VTK). ITK provides leading-edge registration and segmentation algorithms and forms the algorithmic basis. VTK has powerful visualization capabilities, but only low-level support for interaction (like picking methods, rotation, movement and scaling of objects). MITK adds support for high level interactions with data like, for example, the interactive construction and modification of data objects. This includes concepts for interactions with multiple states as well as undo-capabilities. Furthermore, VTK is designed to create one kind of view on the data (either one 2D visualization or a 3D visualization). MITK facilitates the realization of multiple, different views on the same data (like multiple, multiplanar reconstructions and a 3D rendering). Hierarchically structured combinations of any number and type of data objects (image, surface, vessels, etc.) are possible. MITK can handle 3D+t data, which are required for several important medical applications, whereas VTK alone supports only 2D and 3D data. The benefit of MITK is that it supplements those features to ITK and VTK that are required for convenient to use, interactive and by that clinically usable image-based software, and that are outside the scope of both. MITK will be made open-sourc