Patients and professionals need to be assured that the products they use are safe and perform as intended.
Despite the plethora of digital health applications available on the market, adoption rates have remained relatively low. Uncertainty about safety, performance and security, mean patients and healthcare professionals have tended to avoid digital platforms. At the same time, clinical researchers and regulators are hesitant to accept real world data from mobile apps in the home environment as evidence for innovation and development when it comes to new drugs and technologies.
Digital applications that are classified as ‘Software as a Medical Device’ (SaMD) are clearly defined and risk assessed. For consumers, the difficulties arise in relation to non-medical health software products, where medical regulations do not apply. This grey area has less regulatory incentive for validating products in terms of safety, performance and security.
The safety of non-medical health software products is currently regulated under general consumer product safety regulations (GPSD – CPSA), but qualities like performance aren’t always warranted by existing legal frameworks for specific applications. Instead, markets have traditionally favored self-regulation. The absence of applicable benchmarking for non-medical health products also means there is no generally agreed guidance for consumers to consider when making decisions.
Health app evaluation initiatives do exist in both Europe and the US, but their acceptance has been limited and their impact very local. 3 Part of the problem has been a lack comparable assessment criteria and qualified expertise, meaning the evaluators’ scope is often too broad and with variable coverage.
It seems, for non-medical health software products to receive the same level of consumer acceptance as other digital applications, companies may need to adopt voluntary ‘beyond regulatory’ compliance that includes:
- Technical product assessment
- International standard based criteria and methodology
- Testing by qualified experts
- Benchmarked references
SGS Health Software Product Safety Mark
Based on the IEC 82304-1 standard – Health software – Part 1: General requirements for product safety – the SGS HSP Safety Mark is relevant to both medical and non-medical software. It covers products designed for health use, hosted or running on generic devices, and without specific sensors.
The SGS HSP Safety Mark covers products including:
- Software-only products for health use
- Mobile apps running on devices without using specific sensors or detectors
- Laboratory information software
- Radiology information software
- Software for individuals in fitness centers
- Software for finding best conception moment
- Computer-aided diagnosis software
- Analysis software for medical images
- Clinical decision support software used to aid diagnosis, treatment, and health management of individuals
- Individual stress relief software with feedback
- Training plan software for re-validation purposes
- Software for stimulating activity by Alzheimer patients
- Electronic health record systems, including electronic medical record systems
- Hospital information systems
- Health software provided as a service hosted by an external organization
The SGS HSP safety mark has several advantages for developers. These include:
- Improved visibility in the marketplace from utilizing internationally recognized certifier’s product standard mark
- Increased trustworthy reputation afforded by validated evidence from assessments by qualified Medical Device certification experts
- Ability to choose performance, security and Safety First before more other evaluation steps like clinical trials, Health Technology Assessments (HTA) and Health Impact Assessments (HIA) – more cost-effective and sustainable
Undertaking SGS HSP certification also has additional benefits for non-medical health software manufacturers, start-up and SMEs, who will be able to incorporate certification at an appropriate and cost-effective point in their product’s life cycle. For example, if safety, performance and security is assessed following development, but before the generation of technical files, it will mean the data generated will be trustworthy and suitable for international scale-ups. It will also allow progress towards SaMD presumption of conformity, if required.
SGS HSP certification also compels non-medical health software manufacturers to apply the development life cycle tools and risk assessment guidance for software, documentation and Post Market Activity (PMA), but without the additional scrutiny of full risk management and/or a certified quality system. Certification works in a way that will allow future developments towards ‘medical’ presumption of compliance, eventually without re-starting full software development.
The Certification Process
- Step X – Optional pre-evaluation of readiness and weaknesses
- Step A – Tailored proposal from SGS
- Step B – Formal assessment of documents, records and key development system elements
- Step C – IEC 82304-1 certification
- Step D – SGS HSP Mark contract
- Step E – SGS HSP Mark pre-license visit
- Step F – SGS HSP Mark attribution
- Step G – Yearly surveillance visits to check validity and evaluate eventual product changes
- Re-certification assessment after three years
Developers of non-medical health software products need to build trust among end users to create sustainable business models. The low adoption rates often stem from question marks over safety, performance and security. Undertaking SGS HSP certification will allow companies to validate their products against international recognized standards, creating trust among end users.
For further information, please contact:
Division SGS CEBEC Project Leader Medical & Health Products
t: +32 2 556 00 20
1 32,500 Mobile Health Apps Available in 2017
The mHealth Apps Market is Getting Crowded
2 AMA CEO Outlines Digital Challenges, Opportunities Facing Medicine
3 Report of the Working Group on mHealth assessment guidelines