Healthcare apps or medical device apps are becoming more prominent in the area of healthcare management in the community and hospital settings. There is continued growth in the roles of apps used as part of fitness regimes and for social care situations.
For product safety, the general requirements apply to the security and safety of health software products designed to operate on general computing platforms with the aim of placing them in the market without dedicated software. However, now for over four years, the standard does not totally cover the vital rise of health and wellbeing apps.
In the European Union, standalone apps and software that meet the definition of a medical device are still required to be CE marked in line with the EU Medical Device Regulation. This is to make sure they are regulated to be acceptably safe to use and function in the way the developer or manufacturer aims to use them.
Risks Associated with Digital Healthcare Apps
Calibration Risks
As the healthcare app continues to grow, so will the potential risks. The risk becomes much more personal when the safety of the patient is involved which ranges from a slight inconvenience to have a need to call emergency services. For instance, if a medication dosage app gets it wrong by lacing a decimal point in the wrong place, the impact can be fatal.
Latest Regulatory Framework
Digital health providers might be confused about the regulatory landscapes as old standards and regulations are being adapted to meet a variety of scenarios that these solutions throw up. Healthcare regulators worldwide are striving on how to provide a good regulatory framework for innovative services and products. Hence, software developers and users are struggling to understand if the apps qualify as medical devices.
Awareness of Rules of introducing Apps to Market
As the healthcare app market grows, manufacturers struggle to ensure the products get to the market, which creates more concern in the industry about how these apps will be controlled. A fine line exists between a medical device and a medical/wellness app. Hence, developers and manufacturers do not categorize some apps as medical devices when they should be. This is because software developers are not aware of the rules or regulations regards introducing wellness or healthcare apps to the market which results in designing apps that should be categorized as medical devices.
MDR’s Definition of Medical Devices
The Medical Device Regulation (MDR) defines a medical device as any instrument, software, reagent, apparatus, material, appliance, implant, or other article aimed by the manufacturer to be used in combination or alone for human beings for specific medical purposes which includes prognosis, diagnosis, prevention, alleviation or treatment of disease. Quite an all-encompassing definition, if your app falls into the jurisdiction of the MDR that involves significant money, time, and effort. Also, beware, if at first, your health app does not fall within the MDRs criteria, before further iterations or improved release, it may then apply.
Data Privacy
There are issues to consider beyond the MDR as regards data privacy because health apps can have access to personally identifiable, clinical, and highly detailed information about the user. For instance, NHS Digital has emphasized its digital assessment around security on compliance with OWASP best practice guidelines for apps and web-based solutions. While accrediting bodies like ISO27001 and Cyber Essentials are vital, the need to demonstrate suitable vulnerability and security by design testing is also becoming vital.
