Article

Driving patient centric success

The role of Data Interoperability in pharma

Shreejit Nair
Ex CTzen

June 23

Insights

IoT-ification of biosensors and diagnostics devices has led to an explosion of data. This data can now be exploited by pharmaceutical companies across the drug development and rollout value chain.
However, exploiting this data to accelerate and innovate drug discovery remains a challenge due to technical, regulatory, and organizational factors. Data interoperability is the key to solving this challenge.
Data interoperability unlocks three promising opportunities for pharmaceuticals: virtual and hybrid clinical trials, improved medication adherence amongst patients in remote trials, use of remote monitoring in post-market surveillance for improved care delivery.

Data interoperability has long been a subject of focus in the healthcare industry. HL7 published the Fast Healthcare Interoperability Resources (FHIR) Standard in 2013, and since then, the healthcare data ecosystem has evolved significantly. Cloud adoption has sped up, healthcare data usage and privacy regulations have evolved, and new, mature data capabilities have made it easier to exploit data to gain insights.

However, data interoperability adoption remains at a nascent stage from an industry-wide perspective. From the purview of care delivery, this represents a widening gap between the amount of data that is available to be exploited, and that which is actually being used.

With the explosion of telehealth data, the pharmaceutical industry is sitting on a wealth of unrealized opportunities – especially in light of new possibilities that have been unleashed by the pandemic over the course of the last three years.

Here’s why data interoperability is the way ahead, and how pharmaceuticals can leverage it to their advantage.

Data Interoperability: An unrealized potential in pharmaceuticals

Data and analytics maturity has led to the creation of new informatics frameworks to accelerate drug development. At the same time IoT-ification of biosensors and diagnostics devices has led to an explosion of data. This data can now be exploited by pharmaceutical companies across the drug development and rollout value chain.

It is the utilization of growing volumes of data that remains a challenge, from a technical, regulatory, and organizational perspective. Here’s why:

The data recorded or emitted by various devices differs in file formats, and often uses different standards, which makes it difficult to transform and aggregate data.
Collection of patient data is subject to various regulations like the GDPR and HIPAA, which requires anonymization and consent mechanisms.
Various stakeholders in the healthcare ecosystem, from Healthcare Providers (HCPs) to payers, and labs to Primary Care Providers (PCPs), use varying approaches and data standards to operationalize data for their use. An ecosystem-wide approach remains lacking, with a few exceptions.

Over the last three years, the pandemic has ushered a shift in the traditional clinical trial setting, where patients aggregated at central trial administration facilities. Virtual and hybrid clinical trials are now becoming increasingly common, where study coordinators had physical access to the participants.

The value of remote and hybrid clinical trials is well known by now: they widen accessibility to the number and diversity of patients, reduce operational costs, and can improve the time to market for new drugs

Now, the patient is at the center of these studies, and key aspects like participant engagement and adherence, and monitoring of adverse events must be successfully conducted via digital means.

Adoption of home-based diagnostics devices and wearables have now made hybrid clinical trials possible. However, these devices use varying data formats and standards which necessitate data transformations and harmonization. This makes interoperability the key to their success.

Patient adherence to medication schedules is one of the key determinants of the quality of trial outcomes. In traditional settings, physical access to patients enabled study coordinators to keep them motivated and engaged.

In remote and hybrid trials, patients often tend to wean off their schedules. Keeping them engaged is crucial to retaining them, and preserving the outcomes of trials.

By leveraging data interoperability, pharmaceuticals can now generate insights into events of non-adherence, and nudge patients towards ideal behaviors by employing rationales that connect their actions to their quality of life.

Traditional methods of post market surveillance entail data collection from various sources, including electronic health records (EHRs), physician reports, and adverse event reports. These processes are usually conducted manually and can result in delayed drug recall decisions.

With patients using wearables and home-based diagnostics devices, pharmaceutical players can now gain access to this data through HCPs with patients’ consent approvals. Patient data from wearables can now be delivered to PMS workflows which leverage data from other sources like EHRs and social media. This can be used to accelerate recall decisions.

What’s more, patients can be incentivized to share their health data in return for improved care delivery. For instance, patient data can be used to generate recommendations for prescribers to change the medication for patient groups in which they are not resulting in the desired effect.

Data interoperability and the future of pharmacy

The future of healthcare is connected and hybrid. In this future, an ecosystem approach to data sharing will not only enable better patient outcomes, but also lead to more efficient and profitable outcomes for each stakeholder in the care-delivery value chain.

This future rests on the premise of data interoperability. Pharmaceuticals have much to benefit from this evolution. It will not only mean the availability of high volume and quality data for preclinical studies, but also enable interventions on behalf of patients and other stakeholders.

A well-formulated interoperability initiative, operationalized by modern, secure, and consent-driven digital platforms is a crucial first step towards a future-forward vision of the pharmaceutical industry.