Lovkrav vs. udvikling af sundhedsapps

Lovkrav vs. udvikling af sundhedsapps

Health apps give patients better control User Data Social media Pharma Products User behaviour Relatives www Self monitoring (app) data extract Healthcare specialists Self-monitoring Usage

Analytics (anonymous) leads to better insight Data Value from user insights Research Input for further business/ product innovation User behaviour Self monitoring (app) data User extract behaviour Product development Improve/develop on Offerings and/or products Marketing Data for creating more efficient marketing

Insight makes better products Value from user insights User Research Input for further business/ product innovation Social media Pharma Products Product development Improve/develop on Offerings and/or products Relatives www Marketing Data for creating more efficient marketing Healthcare specialists Self-monitoring Usage

Engaging with users the right way is critical and using data in that process is crucial Delight your audience by creating great experience Content creation with analytics insights Engaging with the user Personalize your interaction with insights and function/content options Accelerate innovation by continuously develop functions and content

Classification Class C (by default) No Can a HAZARDOUS SITUATION arise from a failure of the software? Yes Evaluate effectiveness of risk CONTROL measures external to the software No Does failure of the software result in unacceptable RISK? What severity of injury is possible? No SERIOUS INJURY SERIOUS INJURY/ death Class A Class B Class C

Functional risk factors Amplify Interpret Alarms Analysis Calculates Controls Measure Diagnose Converts detects Detects Monitors

ISO 62304 standard development process Management environment ISO 13485 Quality Management System ISO 14971 Application of risk management The foundation to develop medical devices Process standard ISO 62304 Software development life cycle Development and maintenance of a safe software system Affects Implementation of Medical Device software Medical device product standards IEC 60601-1 Medical electrical equipment safety IEC 61010-1 Electrical equipment safety requirements IEC 60601-2 Medical electrical equipment particular requirements Affects Other sources of information Provides additional guidelines and techniques

Class decides needed process & control Class A Software development process requirement Software unit implementation Software release Software maintenance Software risk management Class B Class A + following: Risk control measures in requirements Software architecture Unit testing e c Software integration and integration testing Software verification and documentation Software system testing Class C Class A&B + following: Standard, methods and tool planning Identify segregation for risk control Software detailed design Detailed unit testing Software architecture Software system testing Detailed release documentation

Development effort as function of class Class C: 400% Class B: 200% Class A: 100% Effort

Sample 1 Beregner ikke og viser udelukkende historik af rå selvindtastet data Velfærdstal vises sammen med personlige mål (ikke sundhedstal). App en er ikke forbundet med devices som henter tal automatisk. Påmindelser har udelukkende funktion som en kalender/påmindelsesydelse/generer es og ikke som følge af udslag.

Sample 2 Beregner ikke og viser udelukkende historik af rå selvindtastet data Symptomer vises sammen med indtastede triggers App en er ikke forbundet med devices som henter tal automatisk App en er ikke produkt relateret Påmindelser har udelukkende funktion som en kalender/påmindelsesydelse/genereres ikke som følge af udslag

Summary 1. Result comes at the cost 2. Business case is needed 3. Ensure the best practice See more on www.bridgeit.dk/cases/

BRIDGEIT Thank you Jacob Gliemann Larsen Mobile: 20 31 00 99 jacob.larsen@bridgeit.dk