See how Embleema is spreading digital innovation in Real-World Evidence and Healthcare Blockchain.
“The 21st Century Cures Act (2016) gave the FDA a mandate to accelerate regulatory approval for new treatments that incorporate the perspectives of the patients. This has led pharma to integrate “”real world evidence”” (RWE) into clinical studies. These include Electronic Health Records (EHR), Patient Reported outcomes and connected health sensors.
The problem is that current methods of collecting RWE are costly, slow and inefficient. Contract research organizations (CROs) typically take more than one year to compile RWE manually from industry silos, often completing this with more studies. Per patient cost of trials is $36,500 on average & $16,500 for phase 4. Patients are not compensated when their aggregated data is sold, and do not give explicit consent. Finally, aggregated data does not have the quality of individual patient-level data typically required.
On top of the $140Bn annual drug development market, pharmaceutical companies are buying expensive datasets, as shown by recent deals. For instance, Vertex pays $10,000 per patient per year to the Cystic Fibrosis Foundation. Roche bought Flatiron, valuing cancer patient records at approximately $9,500 a year..
To improve RWE, we replace centralized organizations by decentralized networks with Blockchain. We offer real-time data availability with smart-contracts without intermediaries, reducing time and cost. Allowing patients to set the terms and be compensated for their involvement offers higher resolution individual patient level data.
Yes, we released a public, fully-functional Version 1 of our Embleema health blockchain in July 2018 and a Dapp that runs on it called PatientTruth. You can register at patienttruth.embleema.com/register
GDPR enforces the right to be forgotten, and might appear contradictory with the immutability of the Blockchain. However, the data on the blockchain does not need to identify a patient, and he may erase the private key that links him to his data.
Releasing a public, fully functional and packaged healthcare blockchain and Dapps requires a set of very specific and deep skills: optimize blockchain technology and developments but this is not in our opinion the hardest, deal with extreme fragmentation of healthcare data structures and standards, implement privacy regulations compliance such as HIPAA and GDPR, understand the meaning and use cases of healthcare data within health regulatory frameworks, set-up operations environment particularly hard to stabilize in Ethereum…
Please check out our website embleema.com, and try out our existing product at patienttruth.embleema.com/register or patienttruth.embleema.com/login if you are already registered
We have been featured in foremost publications in the USA, both in the healthcare fields (MobiHealthNews, MedCityNews, PharmaLetter, etc…) and blockchain press (Bitcoin News, Coinjournal, ThirtyK, CCN, etc…) as well as in Europe (LeMonde, Usine Digitale, etc…). You can find links to articles in the Press section of our Ressources page online.
Unlike any of our competitors vying for a space in the emerging Blockchain for healthcare space, we, at Embleema, have a live product with real patients as users. This provides key learnings and metrics to improve user experience, to fluidify data integration from different sources of medical records, or to understand how non-expert Blockchain users interact with the network.
In addition, Embleema has validated with a first pilot with the Cystic Fibrosis community the support of patients for owning and receiving compensation for their data. In terms of clients, we have secured agreement with major pharmaceutical companies to pilot our Blockchain for RWE, including Pierre Fabre.
We also have a solid understanding of the pharma regulatory environment, with existing and frequent interactions with health regulators. The leadership teams brings expertise from IQVIA / IMS – our CEO having led their technology solutions and business in France and Asia – and Withings / Nokia Health, a leader in IoT for health. Our advisers are life sciences experts or technology thought leaders from Harvard Medical School.
In 1951, Henrietta Lacks was admitted at John Hopkins hospital for cervical cancer. Her cells were extracted from her tumour and cultured. They became the HeLa immortal cell line, a source of invaluable medical data to present day, used to develop the first Polio Vaccine, cell cloning and to study HIV. Despite this outstanding contribution to research, Henrietta never gave her consent. She died in poverty with no compensation or acknowledgement until present day.
We believe we have the right as patients to choose how our data is used for the common good. As digital health becomes the norm, this means changing the very organization of the Internet to reclaim control.
The promise of the Internet has been broken. Decentralization of information was meant to promote free speech, democratize knowledge, abolish censorship, expand services remotely… But the Internet is now centralized by a handful of platforms. They monetize our data as their own asset to make us better consumers, not more enlightened or healthier citizens at the expense of working and innovating for the common good. Our data is nothing less than our digital assets in the virtual world and the same way we own and are free to dispose of our assets in the real-world, we should own and dispose of our digital assets.
Our healthcare data is our most valuable digital asset: it can save our life in an emergency situation and provides critical decision-making information for the providers to offer us the best care. However, our records are held captive in protected silos for fear of being singled out, for fear of seeing our right to care violated. A wealth of digital data is lost to personalized medicine.
We want to become the steward of our health data, not having to rely on third parties to handle our most sensitive information. We have the right to break information silos, control where our data is stored, who has access to it, who we share it with. This power can dramatically affect how treatments are delivered, moving away from a top-down approach to an iterative process where we, patients, measure the effectiveness of more personalized treatments. This is a paradigm for medical research and change lives.
As third parties centralize our confidential data, unauthorized access becomes the norm. We, as patients, are kept out of the loop even in case of breaches. Decentralized ledgers let us enforce the security over our digital health assets, making tampering impossible, keeping track of violations in real-time, without no third party involved. Imagine we could still control our data even once it has been shared, removing access to enforce our privacy at any time.
Hospitals or pharmacies monetize our health data to pharmaceutical and insurance companies for marketing or pharmacovigilance studies. Even though there are strong benefits for using our data, we are not taking part in the sale of our own data. Blockchain will let us enforce our property. Smart contracts will let us set the terms by which others access our digital assets. Instead of being robbed of our data, we will willingly get involved and be compensated for our contribution to the development of innovative treatments.
Blockchain as a trust-generating technology is game-changing, destined to become the standard in industries that need trustworthy information without rent-seeking third parties. But its potential is shrouded by a wave of crypto-speculation that make the most solid projects look suspicious. To restore trust and allow news rights to come of age, we deliver real products with clear benefits, demonstrate financial transparency, and share our expertise to the healthcare ecosystem. We are working with regulators, health authorities, pharmaceutical companies, patient advocacy groups, care networks and providers to ensure patients, caregivers and researchers can reliably endorse the next generation of healthcare data.