‘Digital health‘ is on the rise. It’s a term we use more and more often. But what is digital health? What does it mean? After some research, we find all kinds of definitions… It’s still a jungle out there.
Not to worry though: at the QbD Group, we strive to be at the forefront of innovation and share our latest insights and knowledge with you. In this particular blog post, we want to:
- inform you about digital health,
- familiarize you with the key technology pillars of digital health,
- and inspire you with new digital health opportunities within your own healthcare sector (so you can anticipate them).
What is digital health?
One of the most comprehensive definitions of digital health is provided by the FDA:
‘Digital health, or also called digital healthcare, is a multidisciplinary topic that covers concepts that are on an intersection between technology and healthcare. Digital health applies digital transformation to the healthcare field, incorporating software, hardware and services. It can be divided in different categories such as mobile health, health information technology, wearable devices, personalized medicine, telehealth and telemedicine.’
Since digital health applies to different sectors of healthcare, we preferred the FDA’s definition. The FDA defines healthcare regulations, whether in pharmaceutical manufacturing, medical devices, clinical research, or other areas.
QbD’s 4 key digital health pillars
The concept of digital health is built on different technologies. At the QbD Group, we looked at numerous technologies and developments in different industries and grouped them into 4 key technology pillars:
- artificial intelligence,
- and cybersecurity.
1. Blockchain in digital health
Let’s start with “Blockchain“: a buzzword often associated with Bitcoin, cryptocurrency, etc. However, it is a misconception that it can only serve in the financial world.
Blockchain is essentially:
- a list of all types of digital data you can imagine (called a distributed ledger),
- permanently stored among all users (called nodes).
The key feature is that information can be added at any time when all nodes agree that the information is correct and validated or proven. It cannot be copied or deleted in the distributed ledger.
All digital records are stored using a cryptographic signature called a hash. This makes it a secure, immutable system with continuous traceability.
Imagine a world where a complete record of all related data, including storage, transportation, production, etc., can be generated via blockchain for a given medicine.
At the same time, the same blockchain technology protects both data privacy and security throughout the process. All practitioners, patients, researchers, etc. have access to the information they need, without the risk of compromising privacy or security.
Applying this technology can lead to secure healthcare systems in multiple areas, reducing the incidence of fraud and errors. It is precisely because of these advantages that this technology can be used in life sciences.
An example is using blockchain instead of a serialization program to create serial numbers for products. When using a serialization program, it is very easy for counterfeiters to guess the next serial number, whereas when using blockchain it is almost impossible.
To guess the serial number – newly generated by the blockchain algorithm – you need not only the previous serial number, but also the algorithm itself, timestamps of production, and many other variables you can include in the code. This results in increased security and the prevention of forgery.
2. Artificial Intelligence in digital health
The second pillar is Artificial Intelligence (AI). Artificial Intelligence is defined as any technique that enables machines to “think like humans“.
By using this technique, it is possible to improve the efficiency of various decision-making processes, as well as to further drive innovation within an organization. It enables companies to unlock new value in data.
A great example of AI technologies is how Relu offers AI-Assisted Segmentation Software for Dental and Maxillofacial Images.
For more information on how to embed your current validation approach in AI and Machine Learning, read our blog post “AI and Machine Learning validation: strategies and examples.”
3. Digitalization in digital health
Of the 4 pillars we defined, digitalization is the most recognizable one. It is an important step, not only in digital health but far beyond. Data must be analyzed, processed, and used to create new ideas, proposals, and more. But to be able to do this, the data must first be accessible digitally and not on paper.
A first example of this pillar is e-health. E-health is a healthcare practice supported by electronic processes and communication. It has many components, including, for example, mobile health (M-health). M-health is mostly used in the context of measuring and sharing real-time data. Data can be shared via a smartphone app, for example. This new way of working is only possible if data is digitized.
Software as a medical device (SaMD) is also part of digitalization. The IMDRF defined it as:
“software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
SaMD has a wide range of offerings, from visualization apps on your smartphone to software that analyzes data and diagnoses itself.
Some examples include software that displays an MRI scan on your smartphone, software that calculates your BMI or body fat, and software that calculates the most optimal treatment plan, but there’s more! For example, Relu‘s AI-Assisted Segmentation Software for Dental and Maxillofacial Images is currently being certified as a medical device.
4. Cybersecurity in digital health
Another pillar is cybersecurity, which refers to measures, both technological and behavioral, to protect Internet-connected systems from attacks.
There are many different ways to be attacked, but, usually, human error is at the root. The best-known threats are malware, ransomware, phishing and distributed-denial-of-service attacks (DDoS attacks).
Cyber security is important on multiple levels. In healthcare, for example, data must be stored, accessible, and modifiable. Also, data must be able to be exchanged both internally and externally.
Last but not least is the need for compliance and interoperability, which means that both healthcare professionals and patients must be able to view and exchange data.
Therefore, it can be said that data protection is critical to patient safety. As the QbD Group, we will not emphasize the cybersecurity pillar, but ensure that our clients and projects include cybersecurity.
What healthcare sectors will these 4 pillars revolutionize?
Digital health is growing and gaining attention worldwide. The QbD Group aims to support all different sectors of healthcare, from idea to patient.
We strongly believe that digital health is the future, with many applications for emerging technologies in different fields and industries.
We are convinced that digital health (and thus the QbD Group) will make a difference in the following sectors of healthcare:
1. Pharma and Biotech
The pharmaceutical and biotechnology industries continue to make strides in digital health. Paper-based processes have now been replaced by digital systems, such as a quality management system, and cybersecurity is taking on an increasingly prominent role than before, given the many cybersecurity attacks.
Before a medicine reaches the market, it must undergo clinical drug trials. Rapid developments are taking place there as well, especially after the COVID-19 pandemic, with the goal of moving faster and getting products to patients faster.
Many steps still need to be taken in the clinical field, but we see that the process is accelerating, with an Electronic Data Capturing system being just one example of the many possibilities.
3. Medical Devices and IVDs
A final and newer industry or market is that of medical devices and in vitro diagnostics. These products also require performance reviews before they can be marketed.
This market is much younger, on the one hand, and in full swing, on the other hand, whether it is digitalization or any of the other pillars. Electronic Instructions For Use (eIFUs) are just one example of the many possibilities.
What’s next? You decide! Please fill out our poll.
This intro blog post on digital health is the first in a series. In the near future, we’d love to delve deeper into several interesting digital health initiatives by sector, with more in-depth and concrete learnings, opportunities, and examples by pillar. So stay tuned!
But… we need your feedback! Which pillars and sectors are most interesting to you? Please take another 20 seconds to complete our mini-poll (2 questions). We’ll use your feedback to refine the upcoming posts!
Need advise or support?
Do you see the potential of digital health for your healthcare sector, but no idea where to start? Do not hesitate to contact us to see how we can help you implement digital health or provide a framework to bring digital health-based products onto the market.