Seminar Medical Informatics 2015

Transcription

1 Seminar Medical Informatics 2015 Meeting 11 March 20, 2015 Ronald Batenburg UU/NIVEL 1

2 Agenda for today Market and context research for medical apps Target audience, end-users, customers Laws, regulation, certificates Stakeholders 2

3 Developing apps starts with a feasibility study How to get your app accepted by your target audience? How to get your app approved by legal authorities? How to get your app promoted by stakeholders? 3

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5 How to get your app accepted by your target audience? Who is your audience? What are their needs? What are their expectations and attitude towards m-health? 5

6 Do you know where to find? (patients) The number of diabetes patients in a country? The type of diabetes they have? Their gender, age, education, residence? The treatment or therapy they are receiving? The costs of diabetes? 6

7 Do you know where to find? (professionals) The number of GPs in a country? The setting they are employed in? Their gender, age, education, residence? The type of patients they serve? The costs of GPs? 7

8 Some Important Sources OECD/Eurostat Health at a glance Health 4 all database Eurostat Healthcare statistics European Observatory/WHO Health system reviews The Netherlands RIVM, health performance monitor NIVEL, VWS, SCP, 8

9 What are the real needs of patients/professionals? The value proposition approach Customer profile Value map Jobs - Products and services Pains - Pain relievers Gains - Gain creators How can your proposition fit/comply with these needs? 9

10 Question for you: How can your proposition fit/comply with these needs? Customer profile Value map Jobs - Products and services Pains - Pain relievers Gains - Gain creators

11 Specifically: when are users ready to use your app? Diffusion of innovation (Rogers) Technology acceptance models (David, Bagozzi & Warshaw) Task technology fit (Eason) 11

12 The original TAM (Davis, F. D., Bagozzi, R. P., and Warshaw, P. R. "User Acceptance of Computer Technology: A Comparison of Two Theoretical Models," Management Science, 35, 1989, ) Perceived usefulness (PU) "the degree to which a person believes that using a particular system would enhance his or her job performance" Perceived ease-of-use (PEOU) "the degree to which a person believes that using a particular system would be free from effort" 12

13 The successor: TAM2 (Venkatesh, V., Morris, M.G., Davis, F.D., and Davis, G.B. User Acceptance of Information Technology: Toward a Unified View, MIS Quarterly, 27, 2003, ) Both social influence processes (subjective norm, voluntariness, and image) and cognitive instrumental processes (job relevance, output quality, result demonstrability, and perceived ease of use) significantly influenced user acceptance. These findings advance theory and contribute to the foundation for future research aimed at improving our understanding of user adoption behavior. 13

14 TAM3: Unified Theory of Acceptance and Use of Technology (UTAUT; Venkatesh, V., Morris, M.G., Davis, F.D., and Davis, G.B. User Acceptance of Information Technology: Toward a Unified View, MIS Quarterly, 27, 2003, ) UTAUT thus provides a useful tool for managers needing to assess the likelihood of success for new technology introductions and helps them understand the drivers of acceptance in order to proactively design interventions (including training, marketing, etc.) targeted at populations of users that may be less inclined to adopt and use new systems 14

15 Question for you: What fits better for your app and why? TAM1 TAM2 TAM3/UTAUT 15

16 TAM concepts Attitude: Individual's positive or negative feeling about performing the target behavior (e.g., using a system). Behavioral intention: The degree to which a person has formulated conscious plans to perform or not perform some specified future behavior. Computer anxiety: The degree of an individual s apprehension, or even fear, when she/he is faced with the possibility of using computers. Computer playfulness: The degree of cognitive spontaneity in microcomputer interactions. Computer self-efficacy: The degree to which an individual beliefs that he or she has the ability to perform specific task/job using computer. Effort expectancy: The degree of ease associated with the use of the system. Facilitating conditions: The degree to which an individual believes that an organizational and technical infrastructure exists to support use of the system. Image: The degree to which use of an innovation is perceived to enhance one's status in one's social system. Job relevance: Individual's perception regarding the degree to which the target system is relevant to his or her job. Objective usability: A comparison of systems based on the actual level (rather than perceptions) of effort required to complete specific tasks. Output quality: The degree to which an individual believes that the system performs his or her job tasks well. Performance expectancy: The degree to which an individual believes that using the system will help him or her to attain gains in job performance. Perceived ease of use: See the definition of effort expectancy. Perceived enjoyment: The extent to which the activity of using a specific system is perceived to be enjoyable in it s own right, aside from any performance consequences resulting from system use. Perceived usefulness: See the definition of performance expectancy. Perception of external control: See the definition of facilitating conditions. Result demonstrability: Tangibility of the results of using the innovation. Social influence: The degree to which an individual perceives that important others believe he or she should use the new system. Subjective norm: Person's perception that most people who are important to him think he should or should not perform the behavior in question. 16 Voluntariness: The extent to which potential adopters perceive the adoption decision to be non-mandatory.

17 Other integrative model: the Health IT Usability Evaluation TAM ISO Model Nielsen s heuristics Shneiderman s rules for user interface design Norman s principles for design Interviews with users and developers 17

18 The Health IT Usability Evaluation Model William Brown III, Po-Yin Yen, Marlene Rojas, Rebecca Schnall (2013) Assessment of the Health IT Usability Evaluation Model (Health-ITUEM) for evaluating mobile health (mhealth) technology, Journal of Biomedical Informatics, 46(6), ) 18

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20 How to get your app approved by legal authorities? What legal authorities are relevant? What are their requirements? Comply and maintain? 20

21 Laws and regulations Example: A heart rate monitor used in a fitness center is not qualified as a medical device A heart rate monitor used in a hospital to measure the heart rate of patients is 21

22 Laws and regulations - The medical devices act (2) An mhealth application is placed under the medical devices act: If the application makes a diagnosis, Energy is added to the human body by the application or, If the application monitors vital body functions, and variations in this that are a direct threat for the live of the patient 22

23 Laws and regulations - The care institutions act (1) An mhealth application is placed under the care institutions act: If it is applied in anyway by health care professionals And quality of care to patients, and/or the quality of the application is at stake even if it is not a medical device. 23

24 Laws and regulations - The data protection act (1) An mhealth application is placed under the data protection act: If the privacy of the users of the application is at stake, through personal data : Common personal information (name, address, place of residence or cellphone numbers) Special personal information (medical information) If data are used in applications for research or educational purposes, but the app manufacturer has not taken sufficient steps that prevent theft of the gathered data 24

25 A specification of the medical device act: CE certification If an app is considered to be a medical device it is covered by the scope of the Medical Device Directive 93/42/EEC An European Medical Guideline 25

26 CE Certification (1) 1. Is your app a computer program? ISO/IEC :1993: A computer program is defined as a syntactic unit that conforms to the rules of a particular programming language and that is composed of declarations and statements or instructions needed to solve a certain function, task or problem. Not a computer program is e.g. an electronic document with a treatment protocol or a list of results. 26

27 CE Certification (2) 2. Is your app part of a medical device? Then: The software is assessed according to the guidelines of the medical device Any updates to the software are therefore also considered to be updates of the device Not if acts are only performed with regard to storage, archival, lossless compression, communication or simple search 27

28 CE Certification (3) 3a. Is your app not part of a medical device but performing an action on data different from storage, archival, lossless compression, communication or simple search? Yes, if: software is intended to produce results for certain persons, a patient or group of patients, and the app is meant for diagnostic or therapeutic purposes (it is not legally relevant how a user decides to use the app) Not if, e.g., software is intended for statistical purposes or for instance the representation of treatment protocols 28

29 CE Certification (4) 3b. If your app is a medical device, it also has a medium/high risk if: It administers, supplies or exchanges energy It controls, monitors or influences directly the performance of an medical device It administers or removes medicine, energy or other substance to or from the body It is for direct diagnosis or monitoring of vital physiological processes 29

30 Examples of apps that need CE An app Certification: that wirelessly reads the status of infusion pumps and displays this to the healthcare provider that puts the glucose value in a graph and compares it with the normal values representing the heartbeat or other physical parameters during a routine examination monitoring in the intensive care department planning radiotherapy being used to calculate the dose of the ionising radiation for planning an insulin dose 30

31 Question for you: Does your need CE certification? Apply the flowchart!

32 And more certification barriers App certification requirements for the Windows Store 1. Windows Store apps provide value to the customer 3. Windows Store apps behave predictably 4. Windows Store apps put the customer in control 5. Windows apps are appropriate for a global audience 6. Windows Store apps are easily identified and understood 7. Desktop apps must follow additional requirements 32

33 And more certifications (1) App certification requirements for the Windows Store 1. Windows Store apps provide value to the customer 3. Windows Store apps behave predictably 4. Windows Store apps put the customer in control 5. Windows apps are appropriate for a global audience 6. Windows Store apps are easily identified and understood 7. Desktop apps must follow additional requirements 33

34 And more certifications (2) 5.1 Your app must conform to our content and age rating guidelines, and metadata must be appropriate for everyone 5.2 Your app must not contain content that advocates discrimination, hatred, or violence based on considerations of race, ethnicity, national origin, language, gender, age, disability, religion, sexual orientation, status as a veteran, or membership in any other social group 5.3 Your app must not contain content or functionality that encourages, facilitates or glamorizes illegal activity in the real world 5.4 Your app must not contain or display content that a reasonable person would consider to be obscene 5.5 Your app must not contain content that is defamatory, libelous or slanderous, or threatening 5.6 Your app must not contain content that facilitates or glamorizes excessive or irresponsible use of alcohol or tobacco products, drugs or weapons 5.7 Your app must not contain content that facilitates or glamorizes extreme or gratuitous violence, human rights violations, or the creation or illegal use of weapons against a person or animal in the real world 5.8 Your app must not contain excessive or gratuitous profanity 5.9 Your app must not contain or display content that a reasonable person would consider pornographic or sexually explicit 5.10 All content in your app and associated metadata must be either originally created by you (the app provider), appropriately licensed from the third-party rights holder, used as permitted by the rights holder, or used as otherwise permitted by law 34

35 Other security/privacy rules (1) Does the application: Make their security and privacy policy easily available for users? Use services from third parties and is the privacy guaranteed? Explicitly ask to use data that is entered by the user? Make the usage of user data transparent? Only asks data of the user that is necessary for the functionality of the application? Allow ethical hack test performed? 35

36 Other security/privacy rules (2) Can application users: Report security and privacy related problems to the developer? Set a pin code for the application? Delete their account and the related data that has been gathered by the application? 36

37 So ask yourself: Is you mhealth app: - Part of a medical device or person-based diagnosis or therapeutic feedback? - Applied by a health care professional? - Storing, processing or using personal data? - Providing security and privacy assurances? 37

38 To be continued Next Wednesday march 25 38