Intelligent new technologies in the field of medical devices are being developed at a phenomenal pace. Many medical device manufacturers, software firms and pharmaceutical companies are working on new products that are increasingly based on digital integration and mobile applications.
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The development in the field of healthcare products is fuelled not only by a receptive market and the considerable potential for new technical solutions, but also by public projects. For example, the British government has stipulated that 95% of National Health Service patients treated by general practitioners must have access to e-consultation and other digital products by 2020; it is also the government’s intention that by then 95% of tests can be digitally exchanged between healthcare providers. Since October 2015, the US Food and Drug Administration has undertaken a public consultation regarding the use of smartphones, tablets and wearables to recruit people for and conduct clinical studies.
Different stages of development
The possible applications are currently at different stages of development. Digital healthcare products will become increasingly complex and effective. Products with higher risk classes need more time before they can be launched. In many cases, questions concerning clinical trials and validation of the products have not yet been definitively answered. The “app on prescription” already exists. Caterna is one example worth mentioning in this context: several public health insurance providers in Germany already cover the costs of this online vision training for patients with poor functional eyesight (amblyopia). Many other products are still under development or in clinical trials.
Many questions do not need to be clarified just yet
The legal questions reflect the product cycle. Court rulings are to be found in the context of patents and intellectual property. Wearables are known to have been recalled in the non-medical sector. In several lawsuits, the US Federal Trade Commission has imposed fines against providers of health apps on the grounds of deceptive advertising.
A product’s legal classification is an important issue for many providers. In the case of wearables and apps, the distinction is not always clear. Whether or not a medical device is involved is an important matter in connection with the regulatory requirements for market access, product safety and recalls, as well as liability. Various institutions have issued guidelines on the classification of apps as medical devices, such as the German Federal Institute for Drugs and Medical Devices or the British Medicines and Healthcare Products Regulatory Agency.
The European Commission is also working on new recommendations
At present, attention is primarily focused on regulatory principles governing development and market access. In light of more frequent use and longer periods of use, it is already clear that safety measures and recalls, product compliance and duties in respect of instruction and product observation will become increasingly important in future.
Challenges posed by digital products
Technical advances, ever larger dimensions and networking with consumer devices or “more open” networks give rise to new questions in the context of product liability. At first glance, the questions raised under product liability law are the same as those in the past. What’s more, not all applications are really new: telemetry, telemedicine and the integration of medical devices in networks have existed for many years. The digital dimension raises additional questions. The growing use of digital applications has changed product risk profiles. To a certain extent, being networked with consumer devices not only makes the products dependent on consumer behaviour, but also and above all on the software and hardware supplied by third parties. Safety updates, compatibility and network availability are just a few of the challenges to be addressed. In many cases, the software and the vulnerability of systems also depend on user behaviour.
Cyber crime is another problem which must be taken seriously. Hospitals and medical devices are targets for hackers. Attackers exploit the considerable potential for extortion here, due to the associated danger to patients’ health. Data security may become an issue under liability law, as bodily injury cannot be ruled out. Damages may also be claimed for violations of privacy, for instance if health data are stolen and published.
Collecting data may also influence the standard of care expected of those involved. Not only can more data be collected more quickly, they are also constantly available and can be analysed. The owner of the data may be aware – or due to (gross) negligence unaware – of circumstances imposing duties of care. One question that arises particularly in the medical sector concerns the extent to which available data need to be analysed, for instance in the case of real-time data from clinical observation. Moreover, such data are often only available in anonymised form.
It remains to be seen which new aspects need to be clarified in the context of product liability law. The small number of court rulings do not yet provide any indications. Further decisions will follow as new products are introduced. Software and consumer products not destined for use in the medical sector often have a risk profile and error tolerance different to those of medical devices. Cyber security is also a major challenge for healthcare products – particularly when consumer devices and open networks are used. Preventive risk identification and assessment help to address the new issues in this field.