There’s a myriad of digital health terms out there, all of them meaning different things to different people. In some cases, even those well-versed in issues around digital health may encounter phrases that are ambiguous or that they have never heard before.
Having worked with medtech and pharma companies for over 20 years, helping to deliver complex patient-centric solutions, our Business Development Director, Raymond Crosbie, understands the ins and outs of the world of digital health.
In this blog, Raymond explains the meaning behind some of the most essential terms in digital health, and what you need to know about them.
What is ‘digital health’?
Perhaps the most important place to start is right at the beginning: what is digital health?
‘Digital health’ is simply an umbrella term for technology used in healthcare, and includes a wide variety of different tools and systems, from apps, to software, and combination software/device systems.
It’s important to note, however, that not everything digital is a digital health solution. Electronic Health Records (EHRs), for example, are not considered ‘digital health’; rather, they’re referred to as administration system tools in the digital environment.
While EHRs may not be a digital health solution, they’re still important from an integration and a data repository perspective.
The confusion between what falls under the designation and what doesn’t is just one pitfall of umbrella terms like ‘digital health’. By their very nature, umbrella terms will never leave everyone happy. There is already a kind of ‘digital fatigue’ evolving in some quarters of the industry as professionals grow tired of this more general terminology
But while some may argue the ‘digital’ element of health is so ingrained in healthcare systems that ‘digital health’ is something of a redundant term, it’s important to note that these points of view often come from those from digital backgrounds, which implies a particular point of view.
While alternatives like ‘health tech, connected health, or Medical IoT’ are often used, digital health remains the best term we have for the industry.
What types of digital health solutions are out there?
It’s when you dive beneath the umbrella term and uncover the different subsections of digital health that the industry-specific terminology starts to really come up. With such a variety of solutions available – from Fitbit-style apps and trackers, to those used to manage chronic diseases, and even treat physical and mental health conditions, there’s a need for clear distinction.
Let’s take a look at the most commonly used terms to describe these digital health solutions:
Digital Therapeutics (DTx)
The Digital Therapeutics Alliance defines Digital therapeutics (DTx) as “…deliver[ing] medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.”
There are further subsets underneath the term: Prescription Digital Therapeutics (PDTs) and Non-prescription Digital Therapeutics (NDTs). As you might expect, these are differentiated by those DTx that require prescription by a healthcare professional, and those that do not.
The term ‘digiceutical’ (digital therapy) vied with DTx for some time several years ago, but is rarely used now.
DTx may also include combined digital/pharmaceutical products such as Proteus’s ‘digital pill’ (some also reserve the word ‘digital medicine’ for this also, but, as per below, this term is more widely used for other purposes now).
You can find out more about DTx here.
The Digital Medicine Society describes digital medicine as “a field, concerned with the use of technologies as tools for measurement, and intervention in the service of human health.”
Digital medicine encompasses tools like digital companions – solutions such as digital applications and portals that work alongside medication to improve patient engagement and adherence to treatment – as well as drug and combination products.
The term originated out of efforts by The Digital Medicine Society and Digital Therapeutics Alliance to define digital health terminology, with ‘digital medicine’ emerging as a subset that includes DTx and more. That being said, the term hasn’t achieved the same widespread usage as the term DTx, at least for now.
Digital diagnostics are non-invasive digital solutions for disease diagnosis and tracking, often enabled by data, AI and/or machine learning.
The field of digital diagnostics includes digital biomarkers (defined by The Medical Futurist as “data… collect[ed] about health or disease management through digital health technologies to explain, influence and/or predict health-related outcome”), and precision medicine (described by the FDA as “an innovative approach to tailoring disease prevention and treatment that takes into account differences in people's genes, environments, and lifestyles”).
Telehealth is essentially the delivery of health-related services via electronic information and telecommunication technology.
Pre-pandemic, telehealth was starting to be perceived as a somewhat dated cousin to digital health solutions. It’s gained immense importance over the past 18 months, however, as routine medical appointments and other medical functions had to take place outside of the doctor’s surgery or clinic.
Due to the role it played during the pandemic, it’s often viewed simply as “video calls with doctors”. Naturally, telehealth can come in far more complex forms but, as demonstrated by our own research, exposure to such solutions has made people more willing to adopt digital health solutions in general. So, telehealth may well have a longer lease of life than once thought.
Telehealth and connected health were interchangeable terms several years ago, but there is now a clear distinction. Connected health can be thought of purely as technology-enabled care, where healthcare management and delivery is operated utilizing communication platforms and technologies which can be wired and wireless (GSM, LoRa, LTE-M, etc).
The goals and objectives of connected health are to provide a more efficient, effective, and flexible delivery of healthcare services, often remotely. From a patient perspective, this allows more proactive engagement with healthcare providers outside the clinical environment and promotes self-management of care; wearables and connected drug delivery devices are perfect examples in this context.
We can also consider connected health within the confines of a clinical environment, where in-hospital equipment and devices are connected to provide data outputs on patient and treatment parameters for integration with EHRs and as decision-support tools. In parallel, medical device manufacturers will typically use device connectivity to provide a more efficient service, where servicing, consumables, and billing are managed using real-time data.
There are many more subsets of solutions that fall under each of these headings, all with varying evidence and regulatory requirements.
Regulatory terminology specifically associated with digital health is often not a primary focus for pharma or medtech companies: a specialist digital health partner will understand the relevant distinctions and take charge of the process for you.
Nevertheless, you should be familiar with some of the top-level distinctions. One distinction that is particularly important to make is between those solutions that are classified as Software as a Medical Device (SaMD), and those that aren’t.
SaMD is, as per the International Medical Device Regulators Forum, “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Software does not, however, meet the definition of SaMD if its intended use is to drive a hardware medical device or simply fetch data.
Those that are SaMD – including DTx tools – are subject to the rigorous standards of medical devices and must prove they do what they say they should, as well as follow stringent rules and quality management systems around medical device development.
Health and wellness apps, including tools like fitness trackers, lifestyle apps, and nutrition apps, are not subject to the same process.
For pharma and medical device companies looking to assess a potential digital health partner, a track record in developing SaMD, rather than just health and wellness, is a must. Even if the initial product you design isn’t SaMD, even fairly minor improvements may upgrade its classification to where it is then considered SaMD. It’s therefore advisable to use the same quality management system and processes during development of non-regulated solutions as those used for a SaMD solution, to mitigate the risk of complete redevelopment.
Each region’s governing body has its own rules for device regulation, but some of the most up-to-date and robust guidelines come from the EU in the form of the MDR. Anyone launching a digital product in this region should be aware of the SaMD regulations outlined. You can find out more about MDR and its implications here.
What’s in a name?
Whatever terms we use to describe digital health tools, we all have the same aim: to improve the delivery of healthcare and, ultimately, patients’ lives.
To do that, we need clarity, and that means establishing a common lexicon across the industry.
Evolution of that lexicon is inevitable. Terms may change, and new terms may arrive; ideally, many may be ingrained permanently.
We may not be there yet, but we’re making progress. Ultimately, the more we can make ourselves understood, and the more clearly we can communicate the benefits of digital health to all parties involved in the process, and the more quickly we can unlock the benefits of digital health.
Business Development Director,
S3 Connected Health