Table 2.

Detailed description of items of the App-Synopsis for health apps and medical apps.

Item Category	Checklist Item	Sub Items
1. Imprint	1.1 Meta Data	1. Operating system
		2. Version number
		3. Web link (project pages and link to the app store)
		4. Category: Commercial project, non-commercial project, other
		5. Category: public access via an app store, only available to a restricted number of users/experts (in-house), other (please specify)
	1.2 Developer/Distributor	1. Information about the manufacturer/developer
		1.1 Name, address, webpage, contact person(s), email address, phone and fax number
		2. Information about the distributor
		2.1 Name, address, webpage, contact person(s), email address, phone and fax number
	1.3 Sponsoring/Advertising	1. Information about the funding used for developing the app
		1.1 Category: sponsoring, advertisements, other
2. Rationale	2.1 Category	1. Category: medical product or not, if yes: which class; has the app been certified voluntarily (by whom?), uncertified app
	2.2 User group	For each user group:
		1. Specific disease/condition (or as an alternative/addition: which health care professions are targeted, etc)
		2. Gender, age (range), other descriptive items
	2.3 Setting	1. Clinical, outpatient setting, at home, other
		2. Short description of a typical “use case”
	2.4 Purpose	1. Short description of the purpose of the app
		2. Category: information, reference work, educational resources, documentation, diagnostics, therapy, prevention, research, other
		3. Basic description of what the app is to be used for including specific information for the user group(s)
3. Functionality	3.1 Functions and Features	For each available function/feature:
		1. Function (designation)
		1.1 Example
		1.2 Source(s)
		1.3 Category: scientifically accepted, up-to-date content and reflects the current state of science and technology, evidence level if applicable
	3.2 Restrictions and Limits	1. Restrictions and limits of the app
		1.1 Specific description of the app’s restrictions and limits
		1.2 Description of potential or existing risks for the user group(s)
		1.3 Measures that have been implemented to avoid risks for the user group(s)
		2. Already known undesirable effects
		2.1 Detailed description of undesirable effects, if any
	3.3 Usability	1. Methods that were employed during the development cycle
		1.1 Results of usability testing
4. Validity and reliability	4.1 Content	1. Information about the expert(s) responsible for the app’s content
		1.1 Name of the author(s)
		1.2 Description of the qualification of the expert(s)
		1.3 Description of potential or actual conflict of interest
		2. Information about source(s)/reference(s) for all content and algorithms integrated into the app
		2.1 Specific information about the source(s)
		2.2 Evidence level of the source(s)
		3. Studies that have been performed concerning the app
		3.1 Type of the study, references/literature, other evidence
		4. Additional material about the app (test reports, etc)
		4.1 Type of additional material, reference links, ...
	4.2 Quality assurance	1. Information about quality assurance measures that were used  during development
5. Data requisitioning & management	5.1 Data handling	1. Data processing
		1.1 Information about data collection mechanisms integrated into the app
		2. Data protection & privacy
		2.1 Voluntariness of participating in any data collection
		3. Data transmission & storage
		3.1 Purpose of the data collection
		3.2 Who profits from the collected data
		3.3 What kind of and how much data are being collected, at what times (including time intervals where applicable)? In which country is the data being stored? This is especially important considering the differences between data privacy laws and regulations in different countries.
		3.4 Which methods are being used for storing and evaluating the data?
		3.5 Specifics about user’s rights to obtain information about any data that are stored about him; in addition, there must be means to revoke an already given permission to store data. For this purpose, a contact address must be specified.
		3.6 It must also be possible to delete data that have already been stored and the user must be informed about the timespan that is needed until the data are really deleted.
		3.7 Encryption methods and level used for protecting the user’s data during transmission, storage and evaluation. It should also be specified whether it is possible to connect a specific user to the stored data or whether the data are being stored anonymously or pseudonymized.
		3.8 An indication about whether it is possible to prevent data collection and/or transmission and if yes, how this is possible.