Our firm will be attending the EMEA Regional Meeting of Ally Law in Malta next week and on Friday November 15th I will be speaking at a panel discussion titled “Keeping an Eye on AI: Ethical and Regulatory Considerations.”
Artificial intelligence is a hot topic, also in the med-tech field, and poses exciting legal, ethical and regulatory questions. I am sure this will be an interesting opportunity to discuss them with legal and technical experts.
The “Home-Spital” of 2030.
I have enjoyed reading this article on what healthcare may look like in 2030 (in wealthy countries, may I point out). The author of the article says goodbye to the hospital, while welcoming the “home-spital”. She imagines that technology (think driverless cars and robot workers) will help us live in a safer world. Technology will also help preventing certain diseases. Regenerative options will slow down ageing. “You will go to hospital to be patched up and put back on track. Some hospital practices might even go away completely, and the need for hospitalization will eventually disappear. Not by 2030, but soon after”, she predicts.
Healthcare and Technology will be Increasingly Intertwined.
Telemedicine may become so pervasive that hospitals may be empty of patients and filled with patients’ data, continuously fed through wearable patient-monitoring devices or all kinds of sensors. Hospitals may become bio-printing laboratories, where 3D printers will manufacture organs, tissues and bones on demand.
It is somewhat uplifting to imagine that medicine may become so technologically advanced, so personalized and so effective, and health so plentiful. Others, however, warn against the threat of a de-humanized medicine that will solely rely on machines and will be unable to offer a human side to suffering individuals.
Will Technology Render Doctors Error-Free?
While this new world will pose issues of privacy, data security and fraud, will it solve the problem of malpractice? What will be the role of doctors in 2030? Will technology eradicate human error?
Technology is already helping doctors in many ways: drugs, devices, diagnostic instruments are now less harmful, more precise and a lot more effective. Watson computer is assisting oncologists finding the appropriate cure. Simulators helps doctor in their training and in performing surgical procedures. Checklists, protocols and guidelines can be embedded in the doctors’ routine so as to limit, recognize or avoid repetition of human error. We can foresee a world of doctors who follow protocols embedded in devices, leaving less room for deviation from standard practice, but also from mistakes: a computerized doctor, almost. Will this make doctors error-free?
Of Course, Technology can be a Source of Error, too.
The idea of technological devices that are perfectly designed and always perfectly functioning is false, as any product liability lawyer knows. Even the best technology is subject to faulty design of a whole line of products, or faulty manufacturing of a single product.
Malpractice and Product Liability Litigation may Merge in 2030.
Litigation may simply become more complex. In fact, doctors will be sued by patients along with creators of health apps, health data centers, data carriers, device or drug manufacturers, subjects who feed data to 3D printers or who analyze and monitor data processed by devices. It will be increasingly harder to disentangle doctors’ negligence with liability of med-tech, diagnostic or pharma companies. Litigation will rely even more heavily on the opinion of court appointed experts, who will need to be a panel of specialists with bioengineering, medical and information technology skills.
Two classes of doctors will probably emerge, even more distinctively than before: doctors who follow protocols suggested by computers, whose tasks will become closer to those of paramedics, and doctors engaged in research who write protocols that will bind other doctors. The first class will probably see a reduction in its freedom to make medical choices, but may be increasingly shielded from medical malpractice litigation. The protocol-writing doctors will work even more closely with the industry that designs, tests and manufactures medical technology.
Watch Out for the Paradox of Automation!
As this very interesting article (based on an analysis of the 2009 crash of Air France Flight 447, which killed 228 people) suggests, the so called “Paradox of Automation” could come into play. Tim Harford, the author, explains it as follows: “First, automatic systems accommodate incompetence by being easy to operate and by automatically correcting mistakes. Because of this, an inexpert operator can function for a long time before his lack of skill becomes apparent – his incompetence is a hidden weakness that can persist almost indefinitely. Second, even if operators are expert, automatic systems erode their skills by removing the need for practice. Third, automatic systems tend to fail either in unusual situations or in ways that produce unusual situations, requiring a particularly skilful response. A more capable and reliable automatic system makes the situation worse.”
Technology that babysits doctors may ultimately weaken their skills. While automated devices may limit small errors, they may “create the opportunities for large ones”.
Conclusions.
Technology surely helps, who could deny that? But a messianic hope that technology will propel us into a risk-free, error-free and… malpractice-free world is a simplistic approach that is plain wrong.
This post features an interview with Diana Saraceni, founder and managing partner of PANAKÈS PARTNERS , a venture capital investor that finances medical companies, early stage startup and SMEs in Europe and Israel.
Why does Panakés Partners focus on Med-Tech?
Life sciences, especially Med-Tech, have always been an innovative and growing sector. Improving health conditions is one of the goal of developed countries, and new challenges will always face us. Considering this highly changing environment, start-ups and small companies appears to have the best structure to generate innovative solutions. In Europe there are several areas of excellence in technology and chemistry, the ideal environment where promising Med-Tech start-ups can develop. Moreover, European regulatory system has faster and easier protocols for companies to get CE mark and go to market, especially compared to the American system, where FDA approval requires more efforts, both in economic and clinical terms, to enter the market. Lastly, if we consider that western countries invest, on average, 10% of GDP every year on health services and that medical and pharmaceutical enterprises are the most active in acquiring start-ups, the great opportunity Med-Tech represent for us becomes evident.
What are the specific areas where you expect more growth in the future?
Considering the ageing of population and the need of hospitals to optimize their resources and reduce costs, we expect a great demand for technologies designed for home healthcare and chronic pathologies management. These new solutions will allow patients to receive their treatment directly at their own home, letting hospitals to focus their resources on acute pathologies treatment. Furthermore, we are confident that there will be a significant growth in all technologies aimed to a minimally invasive medicine. We are talking about in vitro diagnostics systems or robot-assisted surgery, which will substitute, or at least reduce, tissue biopsies and traditional surgery. Lastly, we expect a great increase in solutions for personalized therapies. These technologies, which combine genetic profiling to Big Data algorithms, will help physicians in the definition of therapies specifically tailored for every patients, increasing the probability of success.
Which countries appears to have the best factors (in terms of legislation, culture, access to funding and applied research) that helps fostering innovation?
By tradition, Anglo-Saxons countries are the ones with a more innovation-oriented policy. Everyone who has interesting ideas is encouraged in developing them, entrepreneurs never stop to look for new opportunities and skip from one project to another, as if they have not realized anything yet, legislation offers benefits to support the creation of new companies. These are the reasons why realities such as incubators and venture capital funds were born and are widespread in these countries. Regarding the specific case of Italy, we can state that the presence of top-class engineers and the excellence of Italy in clinical research in several areas, combined with lower costs than the other developed countries, are the main factors for the success of many Italian start-ups.
Which challenges lay ahead of you?
We received hundreds of requests of funding from companies all over Europe. Now, our main challenge will be to select the most promising ones, both in terms of proposed technology and feasibility of the project. Furthermore, we need to enlarge our network, in order to reach more companies and to find those ones whith the potentiality to change the status of medicine and build up more success stories out of Europe. We like to think of Panakés as a highly entrepreneurial start-up from a certain point of view, with great opportunities and successes just waiting for us!
Law, Health & Technology 