Proposing a standardized, step-by-step model for creating post-traumatic stress disorder (PTSD) related mobile mental health apps in a framework based on technical and medical norms

Figures & data

Figure 1. Blueprint for creating a PTSD-related mMHealth app to standardize development processes for better comparability and testability.

Development: defining the app’s goals necessitates finding an appropriate IT structure. Consider technical norms and specify content for PTSD while adhering to medical norms. Overall, emphasize on interdisciplinary communication between technical and medical teams. Pre-test the product continuously using proven methods. Evaluation: Release candidate is to be tested clinically, using RCTs as gold standard. Results include app’s usability and impact, may lead to return to re-development and repeat evaluation.RELEASE after sufficient evaluation, satisfying outcomes. Post-release tasks are localization and post-market communication.

Table 1. Relevant guidelines for evidence-based treatment for PTSD to base mMHealth apps on.

● NICE Guidelines (NICE, 2005) ● Institute of Medicine Guideline (Institute of Medicine, 2008) ● Kapstadt-Konsensuskonferenz zur Behandlung der PTBS (Stein et al., 2009) ● The ISTSS Expert Consensus Treatment Guidelines For Complex PTSD In Adults (Cloitre et al., 2012) ● The Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V., AWMF) Guidelines (Flatten, 2013), currently under revision ● Australian Guidelines for Acute Stress Disorder & Posttraumatic Stress Disorder (Forbes et al., 2013) ● Management of Acute Stress, PTSD, and Bereavement – WHO recommendations (Tol, Barbui, & Van Ommeren, 2013) ● Clinical Practice Guideline for the treatment of PTSD (American Psychological Association, 2017) ● Va/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder (Management of Posttraumatic Stress Disorder Work Group, 2017)

(American Psychological Association, 2017; Cloitre et al., 2012; Forbes et al., 2013; Institute of Medicine, 2008; Management of Posttraumatic Stress Disorder Work Group, 2017; NICE, 2005; Stein et al., 2009; Tol et al., 2013)

Box 1. Principles for digital development for technology-enabled service delivery programs (Bauer et al., 2018; Digital Principal Working Group, 2018).

1. Design with the user 2. Understand the existing ecosystem 3. Design for scale 4. Build for sustainability 5. Be data driven 6. Use open standards, open data, open source, and open innovation 7. Reuse and improve 8. Address privacy and security 9. Be collaborative

Box 2. Norms concerning software products as medical device.

In the EU: The EU guideline MEDDEV 2.1/6 from 2016 details the requirements for qualifying an app as a medical product. Generally, this is the case if it is designed for the purpose of ‘diagnosis, prevention, monitoring, treatment or alleviation of disease’ (EEC 93/42 Art. 1.2a). As such, it is subject to all relevant EU norms for medical devices. In the US: Contrarily, the FDA utilizes a classification scheme for medical software devices that mostly revolves around listing examples of apps that are to be considered as medical devices (U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, & Center for Biologics Evaluation and Research, 2015). The FDA intends to exercise enforcement discretion for these apps. International: Additionally, there are international norms harmonized by the EU and the US concerning the creation and evaluation of medical devices (IEC 62304, IEC, 2014) and health software products (IEC 82304-1, IEC, 2016). Any apps considered being a medical device should conform to these norms.

(U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, & Center for Biologics Evaluation and Research, 2015)

Table

CDA	Clinical Document Architecture (CDA) is a popular, exible markup standard developed by Health Level 7 International (HL7) that defines the structure of certain medical records, such as discharge summaries and progress notes, as a way to better exchange this information between providers and patients.
FHIR	Fast Healthcare Interoperability Resources, is a draft standard describing data formats and elements (‘resources’) and an Application Programming Interface (API) for exchanging Electronic health records.
GSMA	Global System for Mobile Communications, it represents the interests of mobile network operators worldwide
HL7	Health Level 7; a standards body that defines interoperability and messaging standards for the health industry.
Interoperability	Ability of health information systems to work together within and across organizational boundaries in order to advance the health status of, and the effective delivery of healthcare for, individuals and communities
MAST	Model for Assessment of Telemedicine initiated by the European Commission
MEDDEV	European guideline for medical devices
mERA	mHealth Evidence Reporting and Assessment checklist by the WHO
mHealth apps	Mobile health applications (for smart devices)
mMHealth apps	Mobile mental health applications (for smart devices)
RESTful web services	Representational State Transfer (REST) is an architectural style for designing network applications that specifies constraints, such as the uniform interface, that if applied to a web service induce desirable properties, such as performance, scalability, and modifiability.
UCD	User-Centered Design revolves around integrating prospective users into the design process

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