ABSTRACT
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.
ABSTRACT
BACKGROUND: eHealth potentially can make health care more accessible and efficient and help reduce the workload in primary health care. Homelab is an eHealth tool implemented in a general practice environment, and it offers relatively simple laboratory diagnostic tests without the referral of the general practitioner. After logging in this eHealth tool, patients select and order a diagnostic test based on their symptoms. The test results are presented online to the general practitioner and the patient. OBJECTIVE: This study aims to evaluate the use, usability, and user characteristics of Homelab. Further, it aims to evaluate whether Homelab replaces an appointment with the general practitioner. METHODS: Homelab has been implemented since May 2021 as a pilot in a Dutch general practice. The number of requests and the ordered diagnostic packages are monitored. After using Homelab, patients are invited to complete a short questionnaire. The questionnaire contains demographic questions and assesses usability using the System Usability Scale (10 items). In addition, questions about requesting an appointment with the general practitioner without Homelab are included. All data were anonymous. RESULTS: The questionnaire was filled by 74 individual patients. The mean age of the patients was 40.33 (SD 12.11) years, and half of them were females (39/74, 53%). The majority of the patients were highly educated (56/74, 76%) and employed (53/74, 72%). Approximately 81% (60/74) of the patients reported that they would use Homelab again in the future and 66% (49/74) reported that they would have gone to the general practitioner if they had not used Homelab. The usability of Homelab was perceived higher by the younger age group (mean 73.96, SD 14.74) than by the older age group (mean 61.59, SD 14.37). In total, 106 test packages were ordered over 1 year, and the most requested diagnostic package was "Am I still healthy? I want to do my annual health checkup." Homelab was used the most during the months of the COVID-19 lockdown. CONCLUSIONS: The use of Homelab, a digital self-service for ordering diagnostic tests, was monitored in this study, and its usability was perceived as above average. Our findings showed that patients are willing to use Homelab in the future and they would use it most of the time as a replacement for regular consultations. Homelab offers opportunities for more accessible and efficient health care for both the patient and the general practitioner.