Digital Clinic & Digital diagnostics & Therapeutics

The digital health market has reached nearly 100 billion US dollars in 2018, and continues to expand at a rate of more than 25% per year [1]. With the rapid growth of mobile Internet and wearable devices, digital health products have been increasingly integrated into our lives. Consumers use a wide variety of digital health products to enable convenient digital diagnosis, track and optimize their health.

1. Development of digital clinic & diagnostics & therapeutics

In recent years, with the continuous in-depth development of the digital health industry, many companies and research institutions have begun to try to use digital products (such as software, smart devices, etc.) to help people prevent, diagnose, treat and manage some diseases, so digital medicine and digital therapy. concept came into being.

As digital health is still in a relatively early stage of development, most consumers and medical practitioners are not familiar with the four concepts of digital health (Digital Health), digital diagnosis (Digital Diagnostics), digital medicine (Digital Medicine) and digital therapy (Digital Therapeutics). There is not yet a clear and unified understanding. In this article, we will introduce the definitions of digital health, digital diagnosis, digital medicine, digital therapy products and what are the differences between them.

 

2. Definition and scope of digital health products

We know that both the US FDA and the China Food and Drug Administration divide medical device products into three categories (I, II, III) according to the degree of harm that the product may cause to the human body. For example, medical bandages and pacemakers are medical devices, but the potential harm to humans caused by these two products can be vastly different. Therefore, depending on the classification of the medical device, the supervision of the product and the required clinical trial evidence will vary greatly.

3. Digital Health and digital clinic & diagnostics & therapeutics

he field of digital health are also classified according to the degree of harm (or risk of the product) that the product may bring to users. The higher the risk of the product, the higher the requirements for clinical evidence and regulation. We can see that for the four concepts of digital health, digital diagnosis, digital medicine and digital therapy, digital health is the most extensive concept, which covers digital medicine, digital diagnosis, digital therapy, and digital medicine includes digital therapy. Among them, digital health products have the lowest risk, digital medicine products second, and digital therapy products have the highest risk.

4. Specific applications ofdigital clinic & diagnostics & therapeutics

Digital health products include all digital diagnostic technologies, platforms and systems that can help consumers improve their lifestyle and health.

These products capture, store or transmit consumer health data and/or support life science and clinical operations.

Digital pharmaceutical products include clinical evidence-based software or hardware products that can be used to measure or intervene in human health.

Digital therapeutic products are those software products that are clinically proven to prevent, manage and treat certain medical disorders and diseases.

From the above definition, we can clearly see that digital health is a very broad concept, and all health-related systems can be called digital health products. In contrast, digital diagnosis, digital medicine and digital therapy are more strictly defined, both of which need to measure or intervene in human health. Digital therapy products need to be more effective for a specific medical disease.

6. Clinical Evidence & Regulation of digital clinic & diagnostics & therapeutics

We all know that because of the different risks of digital health, digital diagnostics, digital medicine and digital therapeutics, the clinical evidence of product effectiveness and the regulation it is subject to will also vary widely.

In terms of required clinical evidence:

a. Digital health products generally do not require clinical evidence to demonstrate the effectiveness of the product.

b. Digital diagnosis usually needs to be determined based on specific circumstances, and case analysis is required. Some of them can be said to have to be proved and regulated by clinical data. But some are not needed.

c. All digital drug products require clinical evidence.

d. Digital therapeutic products require not only clinical evidence but also Real World Ourcomes.

7. In terms of supervision and certification by relevant departments (such as FDA, China Food and Drug Administration

a. Digital health products do not need to meet regulatory standards for medical devices and do not need to be regulated by medical-related departments.

b. Digital diagnostics and digital pharmaceutical products are regulated differently. Those digital drug products classified as medical devices are subject to regulatory certification. Those digital drug products used in the development of other drugs, devices or related medical products are only subject to appropriate regulatory review.

c. All digital therapy products must be subject to regulatory review and require regulatory approval for the product’s safety, efficacy and possible use.

8. Product Examples for digital clinic & diagnostics & therapeutics

There are many types of digital health products. Some of the more important product types are listed below:

a. App products directly used by users, such as: lifestyle apps, fitness apps, nutrition management apps, medication reminder apps, etc.

Health information system, such as: electronic medical record system, electronic prescription system, etc.

Patient health information system, such as: personal health record, patient personal home page, etc.

Telemedicine systems, such as virtual clinics, etc.

Clinical experiment related systems, such as: experiment recruitment system, experiment management system, etc.

b. Products in the digital diagnostics and digital medicine category include:

Digital diagnosis, such as: various artificial intelligence diagnosis systems, etc.

Digital biomarker devices capable of collecting and measuring objective, quantifiable physiological and behavioral data.

Remote monitoring of patients, such as: patient medication adherence testing, patient monitoring systems, etc.

Digital companions like: insulin pumps, oral medications with sensors, etc.

Other products: continuous positive airway pressure ventilation systems, cochlear implants, etc.

c. Digital therapeutics are still in a very early stage of development, and there are not many products that have passed regulatory certification, but they can be mainly divided into three categories:

Prevent a certain disease: such as a software system to prevent diabetes.

Manage a disease: such as an app that helps people with high blood pressure manage their blood pressure.

Treating a disease: such as games for children with ADHD and apps for substance use disorders.

9. Summary of digital clinic & diagnostics & therapeutics

A clear product classification is critical to the positioning of digital health products. Different companies and research institutions can better understand the clinical evidence and regulatory requirements for their products according to the risk level of their products.

For users (or patients) who use the product, a clear understanding of the classification principles of different products can better evaluate the possible impact of using the product on themselves.

As more and more digital health products try to enter the traditional medical system (such as entering the medical insurance or commercial insurance system), clear product classification can also enable doctors to better use digital health products in clinical practice.

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