How to improve health technology for clinical application


Carl Reuterskiöld is CEO Qbtechthe technology leader in ADHD assessment and testing.

It’s incredible if you think about the effort that goes into collecting health information around the world. Every year, the medical records of millions of people are used to make diagnoses and decisions about patient care. Sometimes medical records are sent to experts around the world to recommend the most appropriate course of action. It may be considered one of the highest uses of health information.

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

Health tech or health tech is an exciting market full of opportunities. HealthTech, such as smartwatches that can count steps and calculate heart rate, has the potential to help patients improve their health and take more responsibility for their health.

Currently, the healthtech market is primarily driven by the end consumers of these products. Because of this, most products do not qualify as medical devices for use by suppliers to make clinical decisions. While health technology devices can lead to early intervention and improved outcomes for some patients, current market conditions prevent health technology from reaching its clinical potential. Current processes around medical technology implementation and data collection, as well as the lack of regulation, do not provide a clear pathway for clinical progress.

Medtech is more promising given the impact of the biotech and pharmaceutical industries. These industries have established regulatory approval processes. Combining health tech with medical tech is an interesting possibility. Is it possible that innovation in healthtech and the structures and disciplines of medtech have synergies? This seems to be where we find our greatest potential. The growth of the healthtech market requires fruitful results with products that bring real value to patients, providers and health systems.

Combining MedTech with HealthTech

Healthtech is often limited in the data it collects. On the other hand, medical technology, due to its scientific and medical background, is designed to manage large amounts of data that can yield tangible health benefits.

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

Better Health Tech for Better Consumer Health

Europe with its own Medical Device Regulations, which aims to improve the safety, reliability and quality of health and medical equipment available in European countries. This in turn creates an environment in which the device can be applied for real diagnostic and therapeutic procedures.

The U.S. market, in particular, demands improved medical and health technology regulations, just like those developed in Europe. EU regulators ask key questions when researching new health tech or medical technology devices, such as “What is the product for?” They have not been evaluated or regulated by medical or government authorities, making the data they collect unfit for medical purposes.

Consumers driving health tech innovation in the U.S. should ask their own questions: “Why should I download this app or buy this device?” “Can I get a better understanding of my health that I can share with my providers, Or is this app or device just a novelty?” “What kind of data will this collect and how will it be useful to my overall health?” If an individual seeks to improve their personal health or at least monitor it, relying solely on Healthtech is not the solution.

Why Quality Assurance Matters

Consumers looking for products with the potential to improve their health should seek quality assurance, such as FDA clearance or CDC recommendations. You won’t buy a vehicle without verifying that it has passed the proper safety tests, and the same reasoning should apply when looking for a watch or wearable to monitor your health. Healthcare providers also need to determine whether the information from these devices is accurate and usable in a clinical setting. For example, if an app or platform is used to test a patient for ADHD, the data must be useful to the clinician before it can be applied and included in the assessment and final diagnosis and treatment plan.

We’re starting to see interest in European regulations in the US, but regulations don’t mean much without enforcement.according to The latest data, more than 350,000 digital health apps are available to consumers through the app store, and apps that focus on managing illness or health problems account for 47% of the total. Few of these apps have been pulled from the market — underscoring the need for efforts to verify their effectiveness.

Healthtech is heading in the right direction – for example, Apple Watch’s 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 medical tech, device, wearable and app manufacturers must justify the clinical use of their technology. They need approval or certification from agencies like the FDA and CDC to ensure these devices are impactful, valuable and useful for clinicians and patients looking to improve their health.


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