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Drugmakers are acquiring big data firms to analyse patients’ medical records to discover new drugs and improve the efficacy of existing drugs as costly clinical trials have inherent limitations.

Afew years ago, healthcare professionals in developed countries sought interpolable health records to better understand patients’ medical history and treat them better. The focus of this demand was squarely on patients. As the developed countries moved towards electronic medical records, they found an unexpected beneficiary of this: The pharmaceutical companies.

The diagnosis of an aliment, medicine prescribed and its follow-up could give an idea about the efficacy of medicine used. And this could be a treasure trove of information to pharma companies, which are getting bogged down by rising costs of clinic trials.

The drugmakers, however, face two challenges on this front: One, availability of medical records, and two, analysis of vast amount data.

While the data could be collected from healthcare firms, the drugmakers are tying up with big data firms to make sense of their data.

In February, Swiss drugmaker Roche has acquired Flatiron Health for $2 billion. Earlier, it had acquired US laboratory big data company Viewics, which also had an Indian subsidiary in Pune.

Another model that is available to drug companies is sourcing data directly from patients. Recently, Novartis has launched a mobile app, which allows interested patients to share their conditions with the drug firm.

In both the scenarios, the pharma companies need technology experts to make senses of enormous data collected from multiple sources. This is fuelling new interest of pharma companies in technology companies, which experts believe could lead to tie-ups or acquisitions.

Despite the availability of data and the talent to decipher it, the drug makers have hit with a wall in form of privacy laws that restrict sharing patient information to third parties.

In 2017, the UK Information Commissioner’s Office had reprimanded a British hospital trust for sharing the information of 16 lakh patients to artificial-intelligence firm Google DeepMind.

While the advocates of privacy argue against the sharing of patient records to others, the pharma companies claim that they require the records to understand how their medicines work in real time as the traditional clinical trials have intrinsic limitations.

In traditional clinical trials, since there are strict patient inclusion and exclusion criteria, it studies only the effect of a medicine in a homogenous set of people. Patients enrolled in these trials are closely monitored. Patients with more than one disease will not be able to participate in clinical trials even though in clinical practice co-morbidity diseases are a regular phenomenon.

The answer for this conundrum, technology experts claim, lies in the use of blockchain technology, which allows the creator or the owner of information — who typically would be the patient — decide whether or not to give access to any third party. For example, if you have granted access to your data to a clinic, it cannot share the data without your permission to drug firms. If the drug makers want to access your data, they must secure access permission from you afresh.

For those uninitiated, the blockchain technology is a decentralised, democratised yet secure data management system that stores data in blocks which will be accessible to all authorised users. It stores all the relevant data relating to a person’s medical history, treatment and diagnosis.

It allows users to insert information into their health records which includes data from wearable electronic devices such as Fitbits and also reports, X-rays, CT Scans or Mammograms.

The patient databases would always in sync and any interaction with the blockchain will alert all participants, including patients, doctors, health insurance companies, researchers etc, for verification before adding to the log. The blockchain solution ensures data never leaves the originator, instead, a data signature of that information is transferred and stored.

There are, however, other challenges that impede seamless transfer of patient data to drug makers.

Several countries have expressly barred any transfer of real-time Personally Identifiable Information such as which includes age, gender, historic hea-lth record, details of sexually transmitted diseases, among others. Furthermore, adding to the complications, there are different approaches to data privacy and data access in different parts of the world. Apart from privacy, several obstacles must be addressed to harvest the full potential of Real World Evidence. The obstacles include inconsistent adoption of Electronic Medical Records in the medical community, ensuring the quality of data sourced, stored and restrictions on access to relevant data.

With increasing amount of sensitive data and transactions arising from a growing number of stakeholders in the healthcare industry, blockchain technology which is the backbone of bitcoin is gaining steady popularity due to its ability to maintain data.

While the concept of interoperability is practically non-existent in Indian healthcare industry that impedes the adoption of blockchain technology immediately, the global healthcare industry is certainly wants to embrace the blockchain due to extensive possibilities.

A study from IBM found that 16 per cent of the survey participants from the healthcare industry have a solid plan to implement blockchain in a year and by 2020 it is expected that a 56 per cent of the surveyed participants will wish to implement blockchain technology.

The ultimate goal of many players, who are securing real-time data, is to train AI algorithms on the data they solicit using blockchain. With this real-time data, pharma companies can put a check on counterfeit drugs that currently cost around `4,000 crore to the industry.

The blockchain could also make buy medicines easy. Patients could forward to their chosen pharmacy a prescription that is digitally issued by a doctor, and the pharmacy would then provide and bill for the drug. The decentralised validation of these transactions by all network users would prevent billing fraud.

Additionally, using smart contracts can ensure that clinical trials will proceed in the correct chronological order, leading to more reliability, security and transparency.

Leading drugmaker Novartis is using real data for oncology, heart failure treatment and treatment of age-related macular degeneration. They are using all patient data related to heart failure — biomarker, genetics and proteomics — to find additional drug targets for heart failure, thereby linking data that is coming out of the clinic, back to the lab, for further drug discovery.

Even though, blockchain technology is finding use in giving medicines with precision, patient care and outcome research, the biggest challenges in its implementation for data management is engaging regulators early on in the process and making sure they are in line with the goals of deploying it. (Inputs from Ms Kalpana B, Head- Robotics and Cognitive Automation KPMG India; Dr. Subodh Deshmukh, Head Global Drug Development, Novartis India; Kashyap Kompella, founder of Blockchain, India)

HEALTH INDUSTRY IN INDIA LACKS SEAMLESS INFORMATION EXCHANGE BETWEEN HOSPITALS, LABS AND PATIENTS. THE CONCEPT OF INTEROPERABILITY IS PRACTICALLY NON-EXISTENT.