Transforming healthcare: pharmacovigilance, smart pharma and digital health

The pharmaceutical industry is undergoing dramatic change as new technologies bring about rapid disruption. Dr Andrew Rut, CEO of MyMeds&Me, considers how the latest technological advances are helping to improve patient outcomes

Practices that were revolutionary in the pharmaceutical industry just five years ago are now looking outdated and, often, ineffective. Advances in cloud computing, mobile communications, data and AI are all bringing about opportunities and acting as a catalyst for far more effective monitoring, drug development and healthcare treatments, which ultimately means better patient outcomes. 

The focal point of this change is the convergence of pharmacovigilance, smart pharma and aspects of digital health. What unites all three is their focus on data and the benefit-risk profile of various interventions. Each industry sector plays its part in enhancing the capture, analysis and insights gained from data to help deliver better interventions, medicines and services. Ultimately, the convergence enables capture of key information at source and the aggregation of that information to understand individual patterns of disease, responses to medicines or adverse events.

The benefits of smart pharmaceuticals 

For example, one of the biggest benefits that smart pharmaceuticals can offer is the possibility to collect vast amounts of complete data that is unprecedented in its breadth and depth. Digital health businesses are capitalising on the smartphone and smarthome era by introducing consumer-led products that cater to a growing demand for health apps and wearables and are able to complement the data aspect of smart pharmaceuticals. However, with the imminent implementation of the European Union’s General Data Protection Regulation (GDPR), companies will have to ensure that they have lawful bases for processing as set out in Article 6. For instance, the individual must have given clear consent for processing their personal data for a specific purpose. With ever larger and more integrated datasets, anonymisation of the person becomes ever more challenging, as the collection of values can become a ‘digital fingerprint’. 

Pharmacovigilance is helping to revolutionise how pharma companies are conducting clinical trials

This provision of such comprehensive and high-quality data is proving particularly exciting for those in the pharmacovigilance sector who rely on comprehensive and accurate information to drive positive change within the health sector. Pharmacovigilance is a data-driven industry whose success relies on both the quality and breadth of data collected. Pharmacovigilance is helping to revolutionise how pharma companies are conducting clinical trials and capturing adverse drug responses once products are on the market, making assessment throughout the lifecycle far more effective. 

The benefits for healthcare that the capture and analysis of such vast quantities of data could have are many and potentially transformative for many aspects of healthcare. 

The critical role of data 

Recruitment of subjects, plus managing and monitoring them within clinical trials, can be challenging. It can also be problematic to obtain data during clinical trials, or from adverse drug reporting in the field, that is accurate, comprehensive and on a scale that is large enough to paint a complete picture. In the pharmacovigilance sector, completeness and accuracy of data is of paramount importance and is necessary to drive positive change within clinical trials, drug development and the healthcare sector more broadly. 

For too long, medical data has been insufficient, as demonstrated by a Cutting Edge Drug Safety report which found that, despite pharmacovigilance regulations applying a universal framework, there is a lack of industry standardisation in how data is collected, processed and analysed. Overwhelmingly, companies are still using dated technologies to collect information, rather than providing interactive digital tools – or indeed some of the latest methods made available by smart pharma – for reporters or intermediaries to use directly. Using cloud-based platform tools such as the MyMeds&Me Reportum service, which provides a multi-platform solution that enables the standardised capture of adverse event data at source, optimising its quality, gives pharma companies far more accurate data on which to base their assessment and analysis to help produce more refined, effective drugs. 

[Smart pharma] can precisely monitor drug exposure and provide valuable data to both patient and provider

Smart pharma has a vital part to play 

Smart pharma comes into play by offering vast possibilities to accurately capture reliable and comprehensive data at source. When correctly utilised, it can precisely monitor drug exposure and provide valuable data to both patient and provider. An example of this is smart inhalers that are equipped to offer feedback not only on time of intake, but also on critical parameters such as disease control. 

Another example is a ‘digital pill’ recently approved by the US Food and Drug Administration (FDA). The pill includes an embedded sensor that digitally tracks if patients have ingested it. The makers of the pill hope it will offer a unique benefit for patient groups with typically low adherence, specifically those suffering from schizophrenia. While this technology is still in its infancy, there is scope for it to be developed further and, eventually, become an important component of treatment for groups with typically low adherence. It must be used alongside diligent medical care so that patients with paranoid symptoms feel reassured rather than have their condition reinforced. Additionally, the monitoring outputs require protection given that reported poor adherence (whether true or false) can have a detrimental impact on health insurance premiums. 

Digital health complements the picture

Digital health is helping to facilitate a movement towards organised and personalised information that is seamlessly integrated with a patient’s care pathway. It is important that there is a distinction made between genuine smart pharmaceuticals and ‘health apps’, which are more consumer focused. Health apps would include such apps as Azumio’s Heart Rate Monitor, which, when linked to a wearable like an Android watch, can inform its user of their vital signs. However, it is imperative that sponsors assure regulatory authorities of the integrity and reliability of the data collected. Indeed, in 2017 the FDA issued clear guidance on the use of self-monitoring devices: “For mobile technology, validation ensures that the mobile technology is reliably capturing, transmitting, and recording data to produce accurate, reliable, and complete records”.

Furthermore, in a survey conducted by GreatCall, it was found that 93% of physicians think mobile health apps can improve patient health. Additionally, a study by Ricoh Research found that 74% of hospitals that use mobile devices to collect healthcare data are more efficient than those that don’t. The FDA has echoed this sentiment on its website, which reads: “The FDA encourages the development of mobile medical apps that improve healthcare and provide consumers and healthcare professionals with valuable health information. Mobile applications can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it.” 

74% of hospitals that use mobile devices to collect healthcare data are more efficient than those that don’t

It is important to understand how apps are being used and by which population groups. A majority of users (51%) still don’t download any apps in a month. Of those who download one or more apps on average in a month (49%), 13% download just one app. It is millennials (those aged 18-34) who are driving much of the interest in new app downloads, the report finds. 70% say they’re always looking for new apps to try, and are willing to pay for them. One in five of those surveyed downloaded an average of one paid app per month. Other age groups showed little interest in new apps, with only 37% of those aged 35-54 having interest in new and interesting apps. These older groups, however, are the ones most likely to suffer chronic disease that would benefit from monitoring. 

With increased consumer demand, more available consumer tech and clear backing by healthcare professionals, there is, increasingly, a move by tech companies such as Apple, IBM and Google to enter the healthcare sector. Just in early February, DeepMind announced that it had trained its tools and algorithm with data from thousands of retinal scans to detect signs of eye disease more quickly and efficiently than human specialists.

These huge tech firms are well placed to utilise an array of technologies that can provide insights into the patient’s condition. Such companies, given appropriate permissions and consent, are able to collect petabytes of data from patient records, data secured via smart devices and insurance claims to capture valuable data that can help improve the healthcare sector as a whole.

Potential to improve healthcare is vast

Positive change is happening across the healthcare sector. New technologies and the growing role and capabilities of big data are widening access and improving efficacy, in turn bringing huge benefits to patients.

Furthermore, digital health, smart pharma and pharmacovigilance are converging and innovative companies are discovering how to implement aspects of all three to provide best-in-class products and services. Whilst this new era might still be in its infancy, there is significant scope for it to completely disrupt and improve the healthcare sector. 


Andrew is CEO and founder of MyMeds&Me. He is responsible for the delivery of product and company direction, ensuring strong customer experience for all MyMeds&Me clients and building a strong team of enthusiastic, industry specialists who are able to deliver high quality, SaaS products and services to life science customers. Andrew has held senior positions at GSK in the UK, US and Asia Pacific and has extensive experience in driving significant change and innovation within global drug safety operations.

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