Change Killed By Standards

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Novel digital services, such as telecare and mobile applications, introduce an alternative healthcare model. Since it’s an entirely new approach to well-being and health, we can’t apply old measures to check its performance.

Healthcare is one of the most regulated economic sectors — a sector in which products and services affect health and well-being and save or threaten someone’s life. Every country has its legislative frames to determine what is a medical product and what is not. Healthcare institutions regulate trading in pharmaceuticals. To become a doctor, you have to go through one of the most demanding and strict education, complete an internship, and continuously keep learning. To build a hospital, you need to adhere to numerous technical and sanitary standards. The abovementioned regulations concern traditional analog healthcare, in which we have to deal with physical products or formalized services provided in healthcare facilities.

This type of healthcare, assigned to the location and strictly defined by standards, has started to evolve along with digitization. The boundaries between what is referred to as medicines, health services, and services supposed to boost your mood become blurred.

A new system in old frames 

How and when we use healthcare is changing. A medicine can be a mobile application that guides you step-by-step through a chronic illness or physical therapy intricacies. Health services are no longer provided solely in a medical facility’s isolated environment, built upon specific standards that comply with the regulator’s requirements. Instead, doctors see patients at home, at the office, or even on the go. Communication is made possible by a computer, cameras with different resolutions, smartphones with various operating systems, and internet connections whose quality can vary.

What really determines a health service’s quality and effectiveness when it doesn’t fit in the old system? And to what extent is it necessary to follow a strictly defined path to meet essential safety criteria and, at the same time, fulfill the patient’s individual expectations?

Digitalization is not just about to oust classic clinical care and to replace it with new care alternatives. It is about replacing strongly standardized, occasional, and paternalistic care for an average patient with modern, engaged, continuous care. And it cannot be trapped in a framework of recommendations, guidelines, and measures made in the computer-free system.

Here lies the very potential of digitization. It is an opportunity to put an end to the formalized healthcare mega system and decentralize it to take the individual into account and allow every person to function within their personal healthcare system.

Rules against chaos 

I can still remember how the wave of mobile health applications made public institutions, including the European Commission (EC), wonder how they could regulate this new and dynamic trend. In April 2014, the EC published the “Green Paper on mobile health.” 6 years ago, there were 97,000 mobile health applications. Today, there are over 400,000 of them, and hardly anyone remembers the abovementioned document. However, some questions are still valid: How should we assess the quality and usefulness of applications to be safely used by patients and recommended by doctors? How can we distinguish between medical applications and non-medical ones, such as well-being applications? What recommendations should be made for companies developing digital health services?

Old healthcare structures do not fully comprehend the competitive advantage of digital health. The reaction towards something new is a desire to over-regulate it, which leads to nipping in the bud the most significant potential of digital transformation, namely its holistic approach towards health, personalization, and the patient’s involvement. Does the temptation to regulate stems from insufficient knowledge of new technologies and the fear of change? Digital technologies are developing so rapidly that governments cannot keep up with them for a long time. In order to take charge of the situation and regain at least partial control, there are still attempts to trap new solutions in old frameworks. But the reactively implemented rules give the opposite effect. The wave of digitalization will find its outlet in another place anyway. At the same time, the urgent need to determine a broader vision of the digitalization is ignored.

Innovations stemming from decentralization

Today, digital health needs a roadmap, and solutions chosen today by patients will determine the future’s healthcare. Will these solutions respect privacy, ensure compatibility with other systems within the healthcare ecosystem, and give the patient control over their data? Will they be transparent and earn social trust? We need to answer these questions even if they are not easy to be answered, instead of hiding in the panic room and building new barriers for digitalization in healthcare.

The truth is, technological innovations in healthcare are a source of changes that cannot be developed in a centralized and standardized healthcare ecosystem. Experimenting, testing, and observing results in real-time, rather than in the laboratory conditions, are a part of the creative process of designing new solutions. It was the case with telecare services, which were adapted overnight in connection with the COVID-19 pandemic. The theoretical concerns about digital exclusion, quality of service, or technical skills haven’t been confirmed in most cases.

Instead of introducing other digital health legislation, we need to start from a bigger picture of future healthcare. If we want to shape changes that benefit patients, we have to start with a bold vision and draw up a roadmap based on it. And start making changes, even if some evidence is still lacking. Digital health services are too young to deliver evidence in a traditional form, as medicines do.

The danger of moving back from out of the box into the box

The essence of digitization in healthcare is to make the patients, not the system or institutions, the ruler of their own health. Thanks to access to new types of services and sources of information, electronic data exchange, and digital tools, it has become possible.

This is new healthcare and culture, where standardization conflicts with individualization, where the patient is at the center of attention instead of the payer, hospital, or some other organization. And it cannot be build using tools from the previous system.

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