For the sake of simplicity, we are going to refer to a variety of slightly different areas as 'BodyTech':
- HealthTech involves using technologies such as databases, applications, mobiles and wearables to improve the delivery, payment, and/or consumption of healthcare and increase the development and commercialisation of medicinal products.
- MedTech has been described as covering "any technology that can be used in a care setting, which covers disposables, capital equipment and surgical procedure innovations, through to implant technology, biomaterials and connected health IT. Medtech accounts for all devices with which a patient can be diagnosed or treated...".
- BodyTech involves 'enhancing' the body and mind using emerging devices and technologies and is perhaps the most 'Black Mirror-esque' of these groups.
- LifestyleTech has aided people in living and working in a smarter, more efficient and creative manner with gadgets that can turn the most mundane activities into quick and gratifying experiences.
You can then have fun deciding on how to spell these categories. At Taylor Wessing, we've debated the various merits of bodytech, BodyTech, body-tech and so on (well, we are lawyers after all).
But is it really legal?
Such rapid technological advancement has created inevitable hurdles for the law, with potential to stifle development. If the law responds in an overly invasive manner, it risks impeding investment and inhibiting innovation. However, the privacy and general safety and security of users cannot be ignored and, therefore, balance in this area of law is crucial.
Within the EU, BodyTech is partially regulated in the areas of data protection and product safety. There is no specific law applying to BodyTech so these areas are covered under the GDPR and the Medical Device Regulation – but is that really sufficient?
Questions are also being raised regarding the scope of product liability where a healthtech product and/or related app malfunctions or delivers incorrect or inaccurate advice. To what extent can a consumer reasonably rely on the products/advice provided by healthtech product manufacturers and/or related app providers, and when are users expected to identify shortfalls in the offering and take the appropriate course of action for their individual purposes?
Software, electronics and innovative materials are currently being used to develop state-of-the-art, low cost, and more easily accessible prosthetics. However, this process tends to be complex, costly and laden with IP-related issues.
So who is doing what...so far? And what are the broader issues?
HealthTech
- Careology Health Limited offers a service where a cancer patient, their loved ones and their healthcare providers each have a personalised app that puts the patient at the heart of the treatment and provides the tools to enable members of a "Closed Careology Community" to log and view a range of information relating to the patient's healthcare treatment in real time. However, at this stage the Careology tool itself does not diagnose, treat, cure or prevent healthcare issues or make recommendations concerning the patient's healthcare or treatment and in this sense, Careology isn't a healthcare provider. This form of 'app-itisation' in our smartphone-friendly society is shifting the goalposts for the delivery of medical and health-related services and simultaneously enabling individuals to become more hands-on with their health.
- Suffering from Seasonal Affected Disorder? You can now buy a wearable light therapy device that aims to combat this issue by providing a blue light beam to enter your eyes and penetrate your retina.
MedTech
- A new trauma workflow concept is being tested where a patient slides into a CT scanner and, where needed, a doctor can authorise robotics inside that very same machine to immediately perform "emergency therapeutic intervention" for example in the forms of "emergency surgery or interventional radiology". This would certainly speed up the in/outpatient wait times, but would you place your life in the 'hands' of a machine?
- Pacemakers are small devices placed in the body to help regulate abnormal heart rhythms and have now become relatively common place in the medical world. Hackers could, in theory, intercept and take control of a pacemaker and vary the speed of the heart rhythms with potentially fatal consequences. What measures are in place to prevent hacking medical devices? What if the medical device already has malware? Of course there's a reputational risk to the manufacturers and distributors if things go awry; but where does cybersecurity sit with all of this? And it does beg the question: is the murderer still the person with the cloak and dagger, or is it now just the person sitting behind a computer - or perhaps even the computer itself?
- For a number of years, scientists have been giving helping hands to those in need in the form of 3D printed body parts. However, there are murmurs that the next frontier for bodytech prosthetics is in printing and implanting entire vital organs such as hearts, lungs and kidneys. This technology could do wonders for the organ donation waitlists affecting numerous countries - but what are the consequences (and for whom) if an organ turns out to be faulty?
BodyTech
- Applepay and keypads not secure enough for you? No problem; some tattoo parlours are apparently now surgically implanting radio frequency identification microchips into human hands and wrists that can take care of these mundane tasks for you. Then again, smartphones have arguably become an extension to the arms of many individuals, so is it really such a big leap?
LifestyleTech
- Trouble sleeping? 'Sleep robots' have been recently presented in Berlin to help provide rest for the insomniacs among us. Somnox's "baby robot" cuddles you at night, mimics the sensation of rising and falling breath and has an accompanying app on which users can select from a variety of comforting sounds to help lull them to sleep. Perhaps 'SleepTech' is the next big thing?
So what does all of this mean?
The technological advances in the medical and fitness industry to date have changed the way health services are perceived, provided and received. Whether you're a patient, provider or a budding entrepreneur, expect the landscape to continue evolving, creating an ever-more efficient and accessible platform to access health-related products and services.
If you have any questions on this article please contact us.
