Out-Law Analysis | 28 Nov 2019 | 2:53 pm | 5 min. read
Dentists and dental companies that can successfully navigate a complex legal landscape will be well placed to exploit the opportunities on offer in the new digital world.
This is part of a series of articles exploring issues in the dental sector. Other topics include a focus on the impact of consolidation in the UK and Irish dental markets, a look at how reforms are impacting private investment in the sector in Germany, and how collaborative contracts can support digitisation.
Technological change over the past 25 years has been significant, through the advent of the internet and its gateway for e-commerce, to the modernisation of communications, the age of the smartphone and constant flow of data between 'internet of things' devices.
Dr. Nils Rauer, MJI
Developers, service providers and users need to be aware of and consider a multitude of different legal provisions.
Smart home technology is playing a part in enabling digital health and care solutions, and tablets have become a window not only to social media and online entertainment but a source of basic supplies and primary health care.
Allied to this has been the rise of intuitive and customer-tailored mobile apps. The digitisation of the health sector builds on apps that are easy to comprehend and easy to use, regardless of people's age, education and technical proficiency.
The dental sector is perfectly suited to benefit from these developments. Digitisation has already stepped far into the world of dental care.
Power toothbrushes have been at the forefront of connected devices used in the home, but there are further substantial opportunities to build on this as there remain many people who use manual or basic electric toothbrushes to brush their teeth and who miss out on the advantage of the connectivity of more advanced digital brushes. The data that can be gathered on people's daily brushing routine from right where it originates offers the potential to help people take preventative action before dental problems materialise, eliminate flaws in their brushing and in the worst cases enable early detection of disease.
Equally useful are applications addressing the needs of dental practitioners, technicians and clinical staff. Research and dental studies benefit to great extent from purpose-tailored applications. In addition, day-to-day dental care and patient communication can be facilitated through such apps. Mobile communication is time-saving and efficient if being used with adequate diligence. New and prudent solutions are on their way to be marketed. What is fundamental in this context is legal certainty and reliability.
A whole series of legal provisions are relevant to the operation of dental apps. There is no one regulatory framework to be found or a single specific statutory act that sets out the requirements that arise. Developers, service providers and users need to be aware of and consider a multitude of different legal provisions.
Data privacy is of paramount importance, and it is important that businesses take steps to ensure that personal data protections apply to the processing of the information, the IT infrastructure on which the data is held, and the networks over which data is transmitted. In today's digital world, however, it is impossible to guarantee absolute protection for data, but only dental companies and dentists that build their business models and apps with sound cybersecurity in mind are likely to win the trust needed from customers to prosper in the market.
Partnering with the right people and benefitting from their expertise and know-how is essential. In the context of dental apps, successful collaborations are likely to involve advisers and specialists outside of the dental sector to assist with developing slick and innovative IT solutions and ensuring legal compliance.
It is vital that dentists and dental companies seeking to develop dental apps work with their advisers to draw up a bespoke digital strategy suited to their needs and goals. This should be the starting point for getting new dental apps to market and addressing issues such as data privacy.
Of particular relevance to the dental and health sector is the fact that health data is categorised as a 'special category' of personal data due to its sensitive nature. Special rules govern the process of this type of data under the General Data Protection Regulation. Mobile apps must therefore fulfil the highest standards of data protection, and in general they must ensure that explicit consent is obtained to process users' health data.
Best practice on data privacy also rests upon two of the most fundamental principles to be found in the GDPR: privacy by design and privacy by default. This should be reflected in the programming of apps and in the mechanisms that dictate how data collected will be used, such as legal disclaimers, privacy policies and tracking policies.
In the EU there are specific rules that go further than the GDPR that govern the confidentiality and protection of electronic communications. These are set out in the e-Privacy Directive, a piece of legislation that EU law makers are currently in the process of looking to replace with a new e-Privacy Regulation. Any type of dental app is likely to fall within the scope of the e-Privacy regime.
A further EU directive is also pertinent to dental apps as it sets out a range of requirements in respect of patients’ rights in cross-border healthcare. Mobile apps, by their nature, typically allow for cross-border use of the service offered through or facilitated by the application. Therefore, any such service and its underlying terms and conductions must adhere to the patient protections provided for in the directive.
Because of the degree of harm that can arise when health procedures go wrong, promotions for health care products and services are typically measured and reviewed against high thresholds of clarity. This is also true for services rendered in the context of telemedicine, notably dental apps allowing practitioners to interact with their patients.
EU member states such as Germany have enacted specific statutory provisions dealing with advertising in the health sector. Those rules, in simple terms, require certain products and services to only be promoted to a professional audience and not to consumers. In this context, the concept of 'advertising' is considered broadly. Thus, dental app operators must be careful to ensure that the information they provide users through their app relating to certain dental treatments comply with local advertising rules.
It is also possible that a dental app might be considered a medical device requiring certification. Software has already been recognised as potentially falling within the scope of medical device regulation. New EU medical devices regulation were finalised in 2017, though they won't take effect until May 2020. The regulations aim to harmonise the relevant area of law across the EU.
A dental app may qualify as a medical device if it is used in order to obtain a diagnosis, to prevent or monitor illnesses or to carry out treatment. To the contrary, no medical device is assumed if the app serves merely as an information management system, for example as a file for digital records. However, each app needs to be looked at separately since whether they fall subject to the medical device regulations will depend on their specific characteristics.
Dental apps are to some extent already reality today, but future innovation in digital dental care potentially offers practitioners scope to form their medical opinion and recommend specific treatment on the basis of the data collected from day-to-day teeth brushing. It is important businesses in the market explore the legal framework to develop sustainable strategies and products.
28 Nov 2019
28 Nov 2019