September 26, 2022


Carl Reuterskiöld is CEO at Qbtechthe first technology leader in ADHD assessment and screening.

When you think about the effort that goes into collecting health information around the world, it boggles the mind. Every year, medical records for millions upon millions of people are used to make diagnoses and decisions about patient care. Sometimes a medical file is sent to a specialist halfway around the world to recommend the most appropriate course of action. It can be considered one of the highest uses of health information.

At the other end of the scale, most of us have interacted with some means of collecting health data that really doesn’t go anywhere. If you’ve ever used an app that collects minimal health information and offers a nominal incentive to do so, you know that the information is more likely to be used to promote marketing than to improve health outcomes.

Health technology, or healthtech, is an exciting market full of opportunities. HealthTech, like smartwatches that count your steps and calculate your heart rate, have the potential to help patients improve and take more responsibility for their health.

Currently, the Healthtech market is largely driven by the end consumers of these products. Because this is the case, most products do not qualify as medical devices that can be used by a provider to make clinical decisions. While healthtech devices can lead to early intervention and improved outcomes for some patients, the current state of the market prevents healthtech from fulfilling its clinical potential. Current processes around health technology implementation and data collection, as well as the lack of regulations, do not provide a clear path to clinical progress.

Medtech promises more, given the influence of the biotech and pharmaceutical industries. These industries have established regulatory approval processes. Combining healthtech with medtech is an interesting possibility. Is it possible for healthtech innovation to work with the structure and discipline of medtech? That seems to be where we find the greatest potential. It’s a development necessary to make the healthtech market fertile with products that deliver real value to patients, providers and health systems.

Integrating MedTech with HealthTech

Healthtech is typically limited in the data it collects. Medtech, on the other hand, because of its scientific and medical background, is designed to manage massive amounts of data that can produce tangible health benefits.

Can healthtech mature into a market that lives up to its clinical promise? For healthtech to make a real impact, the creators of these devices need to lean further into the medtech industry. If a healthtech device collects specific health data, that data must be reliable and trustworthy for healthcare providers to use in their diagnostic procedures—otherwise, the technology is not being used to its full potential.

Better HealthTech for better consumer health

Europe took a leap forward Medical device regulations, which aim to improve the safety, reliability and quality of health and medical devices available in European countries. This, in turn, creates an environment in which the devices can be applied for actual diagnostic and therapeutic procedures.

The US market, in particular, requires improved medical and health technology regulations such as those enacted in Europe. Regulatory bodies in the EU ask critical questions when considering a new Healthtech or medtech device, such as “What is the purpose of the product?” Most of the “health” apps in the US app stores today may have a vague answer to this question, but they have not been evaluated or regulated by medical or government authorities, so the data they collect is not suitable for medical purposes. .

Consumers driving health technology innovation in the US should be asking their own questions: “Why am I downloading this app or buying this device?” “Am I getting a better picture of my health that I can share with my provider, or is this app or device more than just a novelty?” “What kind of data will this collect and how can it be useful for my overall health?” If the individual is seeking to improve their personal health, or at least monitor it, Healthtech alone is not the answer.

Why Quality Assurance Matters

Consumers should look for quality assurance, such as FDA clearance or advice from the CDC, when looking for products that promise to improve their health. You wouldn’t buy a vehicle without confirming that it has undergone proper safety testing, and that same reasoning should apply when looking for a watch or wearable device meant to monitor your health. Healthcare providers must also determine whether the information from these devices is accurate and can be used in a clinical setting. For example, if an app or platform is used to screen a patient for ADHD, the data must be useful for the clinician to apply and include in an assessment and final diagnosis and treatment plan.

We are starting to see the US take an interest in European regulations, but regulation means nothing without enforcement. According to more recent data, over 350,000 digital health apps are available to consumers through app stores, and apps that focus on disease or health management make up 47% of that total. Few to none of these apps have been withdrawn from the market – highlighting the need for efforts to validate their effectiveness.

Healthtech is moving in the right direction—the Apple Watch, for example The ECG function can detect atrial fibrillation, thanks to its FDA clearance. But there is still room for improvement. To fully bridge the gap between health tech and medtech, manufacturers of devices, wearables and apps must support the clinical applications of their technology. They must obtain approval or certification from agencies such as the FDA and CDC, ensuring that these devices are effective, valuable, and usable for clinicians and patients hoping to improve their health.


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