Wake up to a new morning. Routine day. A wrist bracelet informs the refrigerator about the breakfast menu, in line with a new diet you decided to try. Your electric toothbrush warns of an impending gum inflammation. Need coffee before all these notices. “Mom, I’m not feeling well” yawns the toddler. Hand on forehead. Hmmm… Maybe he’s right. I attach his bracelet, which recommends a home swab test. If you don’t do it, the bracelet will inform his nursery school and he won’t be allowed in. Since Covid-19, way back in 2020, they’re very sensitive. Swab the child’s throat, during a sip of coffee (Thank God there’s still coffee in 2030!). Warn partner it’s his turn to stay home. Another alert from the bracelet. Warning: Your father again forgot to take his blood pressure meds, and due to a slight sign of depression in his voice, a visit or encouraging conversation is suggested. OK. Need to speak with dad on the way to work. Yet another alert: This time from the children’s clinic. The pediatrician is unavailable now. Substitute, a medical artificial intelligence software, determines that according to the data, the diagnosis is that the child is well. Yay! Off to the nursery. In the afternoon the child’s temperature rises. The physician already wrote that the prescription is on the way.
Though this future morning somewhat resembles a typical morning in 2020, it’s very different. However, some of these technologies already exist today.
“Digital health” means employing state of the art technologies to enhance medicine and medical treatment.
Digital health encompasses a broad range of technological capabilities: these include programs for medical data management by the patient, programs to manage patient flow in medical institutions; medical devices that monitor patients’ health condition at home, tele-medicine technology for conducting remote digital medical meetings, AI-based programs that analyze medical images and data, generate medical insights and assist the physician in decision making, or detect errors in medical judgment as a control mechanism.
Due to the Civid-19 pandemic, the use of digital health tools has been significantly accelerated. Covid-19 obliterated psychological, organizational, and in some cases even regulatory obstacles to these tools. Thus in the struggle to combat the pandemic, artificial intelligence is being used for vaccine development, pharmaceutical research and for generating predictions on the spread of disease. We also see the use of tele-health for digital medical encounters and digital prescriptions, the use of medical wearable devices for remote monitoring in hospital wards and in the patients’ homes and the use of virtual reality to instruct medical staff and improve medical care.
The medical field generally, and digital health in particular, is heavily regulated. In Israel and abroad there are hundreds of laws, regulations and directives that may impact companies and their products. It’s essential to be familiar with and understand them. One shouldn’t develop a product and discover only at the end of the process that there are significant legal and regulatory obstacles to commercialization. It is important and much advised to plan ahead during the development stage, and design products while taking into account legal requirements and regulations.
Registration requirements for medical devices – even software programs may under certain circumstances be considered medical devices requiring registration with the Ministry of Health or regulatory authorities abroad;
Want to test your product through clinical research? This is subject to specific regulation.
Developing artificial intelligence? Currently the U.S. FDA (Food and Drug Administration) is developing instructions on the subject, and initial drafts have already been published. It’s worthwhile familiarizing oneself and understanding where regulations are headed in this field.
Stay tuned for a discussion of legal requirements for tele-health products, medical applications, Artificial Intelligence and more in upcoming posts.
This post is intended to present general information only. It should not be construed as legal advice or a legal opinion and should not be relied upon as such.