A company that has developed a healthcare blockchain network for secure sharing of medical records is coming out of stealth mode.
Embleema, based in New York, said Tuesday it would launch a beta version of its personal health records blockchain and app, built on the smart-contract platform Ethereum. The company said its goal is to solve challenges associated with collecting and safely sharing real world evidence, restoring precision and transparency in the healthcare and clinical trials industries by allowing patients to consolidate, own and share data with healthcare stakeholders and be compensated through cryptocurrency for doing so.
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Embleema’s product consists of the blockchain that contains the data and a decentralized app, PatientTruth, which stores and uses the data on the blockchain, CEO Robert Chu said in a phone interview. The company has raised $670,000 in seed funding from friends and family toward a goal of up to $1 million this year and will likely open a Series A round next year, he said.
The current approach to post-marketing surveillance is inefficient, requiring months to years for drug companies to hire contract vendors and find doctors, Chu said, and the FDA often challenges the quality of real-world studies.
The clinical trials in which drugs are developed often fail to capture the efficacy of drugs in a real-world setting, and 32 percent of drugs approved by the Food and Drug Administration face safety events after their approval and launch that prompt regulators to demand direct access to post-market raw data, according to a study published last year in the Journal of the American Medical Association, based on data from 222 drugs approved between 2001 and 2010. According to the company, current real-world-evidence studies rely on low-resolution, aggregated data sets sold by third-party data brokers rather than high-resolution, individual patient data, incapability of long-term monitoring and incapacity for secure individual consent.
Embleema’s approach allows patients to put their real-world data on the blockchain and, if they choose, authorize drug companies to access it in a deidentified manner and thus detect safety and efficacy signals early on and over long periods of time, Chu said.
Embleema is currently working with a couple of drug companies, Chu said, describing them as one of the top-five global pharmaceutical companies and a mid-sized, oncology-focused company, which Embleema should be in a position to announce publicly in September. Its pilot customer is CysticFibrosis.com, according to the Tuesday press release. With cystic fibrosis patients’ concern hat their data could be sold without their knowledge or consent, blockchain allows them to share data on their own terms, the press release quoted website founder and patient advocate Jeanne Barnett as saying.
The global market for blockchain in healthcare is expected to reach $5.61 billion by 2025, according to a report released in May by ReportBuyer, representing 63.85 percent growth from its current market size. Less than 10% of healthcare organizations regularly share medical information with providers outside their organizations, and lack of interoperability and limited linkage between healthcare storage systems makes transmission, retrieval, cleaning and analysis difficult, according to the report, meaning most of the data is in silos. Growing concerns about security and privacy have thus led blockchain to be touted as the panacea for the interoperability and security issues.
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