Health Technology Special Feature

How technology is revolutionizing the way patients are diagnosed and treated

By Michael Lieberman, Ph.D., Senior Vice President of Medical Science at Klick Health


The World Health Organization defines health technology as “the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives.” While that’s true, it’s a pretty broad statement. In an era when we’re seeing rapid technological shifts in the way people measure, monitor, and think about their health, it’s worth focusing any discussion of health technology to a few key areas that best highlight some of the more exciting – and challenging – aspects of health technology development at this point in 2021.

Two places where we’re seeing some of the biggest changes in the health technology landscape are in how health measures are being tracked and recorded, and how people are getting their medications to treat their conditions. Our experience in both areas has shown that to create technology that helps companies meet their commercial goals, there must be a deep understanding of the disease state from both a provider and a patient perspective, paired with a fundamental analysis of the business problem they are looking to solve before implementing it.

A key area where data recording and tracking has grown is in the use of wearables. Wearables have quickly gone from being innovative to being ubiquitous.

Source: Statista










With more than a fifth of the U.S. population owning some form of wearable, the question for manufacturers has become less about how to consumers to purchase, and more about how to add meaningful functionality.

What started out as simple pedometers now have the ability to take ECGs, have integrated blood pressure cuffs, and potentially even estimate people’s blood glucose levels. Major technology players, including Apple, Google, and Amazon, have all stated that they view the healthcare space as a place for future growth.

The Apple Watch platform has served as the primary focus of Apple’s digital health ecosystem to date. As successive models have been released, additional features and analyses have been incorporated. While Apple has been relatively quiet about their overall strategy to grow their footprint in healthcare, the approach appears to be two-fold. The first is the steady incorporation of new digital “general wellness” health measures that do not require FDA approval pathways. This list includes common health trackers like heart rate, as well as items that, a decade ago, would have required expensive inpatient monitoring, like detection of atrial fibrillation. The second is the usage of their platform to develop digital biomarkers.

Digital Biomarkers

Digital biomarkers are digital surrogate measures that utilize technology to non-invasively track health-related conditions. 

Source: Klick











Digital biomarkers have multiple advantages over conventional biomarkers (lab tests, imaging modalities like MRI, CT, etc.). They are less expensive to capture, and, because of their ease of measurement, they can be done in more real-life settings to better get a sense of what patients’ health looks like outside of a strictly clinical context. This means more relevant data and having more data over time will unlock the potential to apply more sophisticated analysis techniques to previously oversimplified results. For example, a blood sugar measurement is a single snapshot in time. But a continuous measurement of that blood sugar allows technology to mathematically model how that measurement changes and extract unique features from those changes. Our Applied Sciences team has published data showing how application of complex mathematical models originally developed for torpedo guidance to continuous blood glucose data can unearth entirely new glucose control “phenotypes,” or a mechanism of keeping blood glucose in control. These results are being explored as a way to assess the likelihood of a someone with diabetes responding to a therapeutic intervention before it’s implemented – and potentially helping them get their glucose under control much more quickly.

Apple has been partnering with pharma companies to develop digital biomarkers of its own. Biogen, for instance is collaborating with Apple to use the Watch platform to digitally track cognitive changes in Alzheimer’s patients to better assess response to therapies, like the recently approved Aduhelm. Apple is also working with Janssen in the Heartline study to determine whether Atrial Fibrillation detection on Apple Watch, combined with an app, can improve clinical outcomes by reducing the risk of stroke.

Verily, the health technology-focused arm of Alphabet, has also been looking to develop digital biomarkers of its own. They successfully gained approval from the FDA for their smartwatch-based detection of irregular heartbeat in 2020. However, in January of 2021, Verily submitted a letter of intent to FDA for COA qualification of its digital biomarker for Parkinson’s disease. That digital biomarker consisted of several digitized versions of the standard measures used to track progression in the disease. The “virtual motor exam” component was meant to replace the laborious MDS-UPDSR part III exam that is considered the gold standard for motor assessment in clinical trials in Parkinson’s Disease. This digital replacement consisted of a combination of finger tapping, hand opening/closing, foot stomping, and standing still as monitored remotely. The FDA didn’t agree. On June 8th, the FDA responded by rejecting Verily’s application, asserting that the changes being measured “cannot be interpreted as being meaningful to patients.”

The takeaway message is clear: the ability to measure something, even if it is directly impacted by the disease in question, does not seem to be of particular interest to regulators if the measurement doesn’t also have clear clinical and patient utility associated with it. We don’t see this as the end for digital biomarkers, but rather the early beginnings and a signal that technology needs to be effectively married with clinical and regulatory understanding to be considered relevant to regulatory bodies and healthcare providers.

How people are getting their medications

It doesn’t seem so long ago that there was one place where people got their medications: their local pharmacy. Either over the counter (or behind the counter, in some countries) or from a pharmacist dispensing a prescription. That was it. But even before the pandemic, things were starting to change, and COVID-19 has accelerated those changes in ways that are set to fundamentally alter the way companies think about how and to whom they’re dispensing their medications.

In 2013, as part of a continuing effort to encourage drug manufacturers to consider switching their prescription-only drugs to over-the-counter status, the FDA passed the Non-prescription Safe Use Regulatory Expansion (NSURE) initiative. Supporting this guidance, in 2018, it was updated to include recommendations on how technology could be used to facilitate these switches. The key hurdles to many previous switch attempts were drug facts label-comprehension, appropriate self-selection and deselection, and actual use of products. Citing technology, including digital questionnaires, in-store kiosks, and smartphone-based mobile health applications, the end state is better for all stakeholders– switching drugs to OTC saves a considerable amount of money in drug expenditures for insurers and health systems, increases the availability of needed medications, and reduces unneeded HCP visits for medication prescription refills. Despite considerable fanfare and hope that NSURE would create a quicker path towards OTC switches, however, the rate at which switches have occurred has been surprisingly low – until recently. The FDA did not approve a single switch in 2018 or 2019, but approved six products for switch in 2020, suggesting that the updated guidance has opened new doors for companies looking to make the switch.

Our consulting team has been working with several Rx- to-OTC switch teams in the industry to determine where appropriate integration of technology can make the difference in an FDA submission. While specific details are confidential, we can highlight a few areas where technology integration appears to make a difference.

  • Appropriate self-selection is a key factor in FDA considerations, but most people don’t carry the comprehensive lists of their lab values that might make specific OTC meds appropriate for them in their heads, or typically even written down. This means in a point-of-purchase context, people won’t know if from a medical eligibility standpoint whether they should be buying an OTC drug or are disqualified from using it.
  • Smartphone-based EHR-integrated tools that can rapidly access prior labs, when paired with electronic questionnaires, can boost self-selection accuracy – and help deselect potential consumers who might have dangerous drug/drug interactions, for example.
  • We anticipate more and widespread adoption of technology-based solutions to answering the question of how you effectively switch a drug from Rx to OTC – and an earlier consideration in product life cycle, as to how a switch can be planned and technology can be effectively incorporated to ensure success.

Beyond making prescription medications more accessible through retail pharmacies, the availability of electronic prescribing over the internet has also had a significant impact on how patients can get the medications they need. As most people know, the volume of telemedicine appointments skyrocketed during the COVID-19 pandemic.

Source: Statista











As people are becoming more comfortable talking to their healthcare providers over the phone and the internet, they’re also becoming more comfortable having their prescriptions written online. Women’s and Men’s health online prescriber hims & hers showed a mind-boggling 80% YoY growth in 2020; primary care-focused PlushCare was recently acquired for $450 million; Doctors on Demand volume increased 139% in 2020; and even more niche players like Lemonaid Health are having oversubscribed funding rounds due to unprecedented volume.

Michael Lieberman

Clearly, people are rapidly becoming more comfortable with having some of their medications prescribed online, without in-person, physical exams. Combined with a wider range of formerly prescribed medications available in-pharmacy, technology has made it easier than ever for people to get their prescription drugs without a visit to a doctor’s office. Our consulting team is helping an increasing number of pharmas and biotechs looking to broaden their footprint online by identifying appropriate partners and online channels for their products, then helping establish valuable partnerships between the organizations. Prior to the pandemic, these companies would have relied exclusively on sales-rep driven approaches to marketing and selling their medications. Now, thanks to technology, they can make adoption of their products faster and easier.

The common thread across all of these developments in health technology: the availability of individual healthcare data that is more relevant, more plentiful, and more easily accessible is letting both consumers and healthcare providers make more informed decisions about health more easily.