May 18, 2018 – SGS's HSP Safety Mark provides health software developers with the ideal tool for improving trust in their products and increases adoption rates for mobile health applications among professionals and patients.
Research2Guidance identified over 325,000 mobile health applications available on the market in 2017. Despite this, adoption rates have remained low because of a lack of trust in the product. Both professionals and patients have acknowledged uncertainties about safety, performance and security, while clinical researchers and regulators remain hesitant about accepting real-world data recorded on these apps as evidence for innovation and development of new drugs and technologies.
The problem is particularly acute for non-medical health software products. While digital applications that are classified as ‘Software as a Medical Device’ (SaMD) are already clearly defined and risk assessed, non-medical health software products are not similarly regulated. Without that regulatory push to valid the product in terms of safety, performance and security, there is always going to be a problem of consistency, which can be confusing for consumers and professional end users.
Digital applications are currently regulated under general consumer product safety regulations (GPSD – CPSA). To promote trust in these products, however, the product needs to prove it can be relied upon and qualities like performance aren’t always warranted by existing legal frameworks. Without applicable benchmarking and no generally agreed guidance for consumers, it can be difficult for the consumer to know if the product they are buying is fit-for-use.
The market has so far largely relied upon self-regulation. Health app evaluation initiatives do exist in Europe and the US, but their acceptance has been limited and localized. Without comparable assessment criteria and qualified expertise for these items, the scope taken by the evaluator is often too broad, which means coverage can be variable with unstandardized results.
To improve the level of consumer acceptance therefore, manufacturers of non-medical health software products need to adopt voluntary ‘beyond regulatory’ compliance procedures that include:
• Technical product assessment
• International standard based criteria and methodology
• Testing by qualified experts
• Benchmarked references
SGS’s HSP Safety Mark covers both medical and non-medical software. It is based upon IEC 82304-1 – Health software – Part 1: General requirements for product safety, and covers products designed for health use, hosted or running on generic devices, and without specific sensors.
Benefits for developers 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
Certification can be incorporated at convenient points into the development and production life cycle of the product – a major advantage for non-medical health software manufacturers, start-up and SMEs. For example, if safety, performance and security is assessed following development, but before the creation of technical files, the data generated will be trustworthy and suitable for international scale-ups. This data can also be used for SaMD presumption of conformity, if required.
SGS HSP certification also compels non-medical health software developers 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 eventual developments towards ‘medical’ presumption of compliance, without the necessity to re-start software development.
The certification process is:
• 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
The SGS HSP Safety Mark is applicable to a wide range of 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
Developers of non-medical health software products need to build trust among end users to create sustainable business models. The low adoption rates can be reversed if developers prove their products are safe, secure and perform well.
SGS Medical Device Services
SGS offers a comprehensive range of medical device testing, certification, auditing and training services to help manufacturers navigate the complexities of international medical device regulations. Working with SGS helps companies bring their products to market quickly whilst ensuring compliance with the required regulations and standards. To learn more about SGS Medical Device Services: [www.sgs.com/en/consumer-goods-retail/medical-devices].
For more information, please contact:
Division SGS CEBEC Project Leader Medical & Health Products
Tel: +32 484 81 13 53
Email: crs.media ( @ ) sgs dot com
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.
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