PatientTruth Decentralized Health Record Prototype Completed allowing patients with medical records under US format to upload their data on a blockchain<br /> <br /> (https://patienttruth.embleema.com/login).

CEO of T-Systems Management A. Al-Saleh joins advisory board, as well as serial life sciences entreprenur Bernard Gilly, president of iBionext Startup Study and Pixium Vision, and F. Duchesne, CEO of Pierre Fabre Pharmaceuticals, adding credibility and support from industry leaders to Embleema's vision

Embleema, today emerged from stealth, to launch the public beta release of its patient-driven, HIPAA-compliant, personal health records Blockchain. Built on Ethereum, the leading smart-contract platform, and available today after one year of R&D, Embleema aims to solve the challenges associated with collection and safe sharing of Real World Evidence (RWE). Embleema restores precision and transparency in the healthcare and clinical trials industry, by allowing patients to consolidate, own and directly share their data with healthcare stakeholders, and receive payment via cryptocurrency tokens for their participation. Embleema’s leadership team holds more than 100 years of industry experience in life sciences, healthcare data, wearable, digital health and Blockchain technology across the US, Europe and Asia-Pacific. <br /> <br /> <br /> “We focus on real data from real patients in the real world, and our mission is to turn the bottle upside down and put patients first in the healthcare system” said Robert Chu, CEO and Founder of Embleema.” Blockchain removes the need for third parties to broker the sharing of patient data, which is a multi-billion dollar industry, while providing the most accurate data possible for precision medicine to succeed and allowing patients to maintain sovereignty over their data. ” Chu left his role as Senior Vice President, Global Technology Solutions at IMS Health, a global leader in healthcare data, to found Embleema in June 2017. <br /> <br /> <br /> Today, drugs are primarily developed with data collected in controlled research environments, which fails to capture the efficacy of treatments in real-life setting. 32 percent of drugs approved by the FDA are affected by a postmarket safety event, prompting regulators to demand direct access to post-market raw data from life sciences. Current methods of gathering data on adverse effects and efficacy are slow, and lack precision due to the absence of active patient involvement. This has worsened public health crises, generating a vicious circle of distrust between between patients, life sciences, and regulators, and is delaying the availability of new drugs to patients. <br /> <br /> <br /> Giving patients complete control over their healthcare data:<br /> <br /> Embleema’s health blockchain and decentralized app (DApp), PatientTruth, enable patients to assemble the full picture of their health from multiple sources. It rewards them with crypto-tokens for securely storing medical records generated by their multiple healthcare providers through uploading of HL7 Continuity of Care Documents (CCDs) as well as data from connected health devices, beginning with Fitbit. <br /> <br /> <br /> "With a decentralized public ledger, patients can truly be the stewards of their own data. Blockchain infrastructure provides three benefits — a ledger of where a patient's records are to be found, smart contracts to determine who can access those records under which conditions, and security keys to ensure only authorized parties access the data under the patient’s terms. Blockchain isn’t here to replace Electronic Medical Records (EMRs), but to create more balance within the healthcare system by giving patients complete control over their treatment and how their data is used.” - Dr. John D. Halamka, International Healthcare Innovation Professor at Harvard Medical School, Chief Information Officer at Beth Israel Deaconess Medical Center, and Embleema advisory board member. <br /> <br /> <br /> <br /> Today, RWE studies suffer from three major deficiencies that lead to poor findings:<br /> <br /> -Reliance on low-resolution aggregated data sets sold by third party data brokers, rather than high-resolution -individual patient data <br /> <br /> -Inability to monitor the same patient over extended periods of time, which allows for much better research and drug development <br /> <br /> -Loose individual patient consent collection, <br /> <br /> <br /> Embleema’s blockchain allows patients to consent to real-time data sharing with pharmaceutical companies and healthcare authorities.This will improve real-time detection of safety issues and assessment of efficacy down to the patient level, and benefit the entire health system.<br /> <br /> <br /> Features of PatientTruth V1 Decentralized Application:<br /> <br /> -Visualization of Medical Histories and Fitbit activity data shared by patients<br /> <br /> -Upload Continuity of Care Documents (CCD) medical records into blockchain, with further support of other HL7 and -FHIR interfaces in the future<br /> <br /> -Upload of Fitbit information into blockchain, with further integration of other connected devices in the future<br /> <br /> -Medical History stored securely on blockchain<br /> <br /> -Authorization management for the sharing of the Medical History<br /> <br /> -Audit-trail of personal Medical Records accesses<br /> <br /> Compensation in tokens for uploading CCDs and Fitbit information, as well as referrals of new patients and providers<br /> <br /> <br /> Patients and healthcare professionals can be the first to use the Embleema health blockchain and PatientTruth Dapp by joining the community at https://www.embleema.com. These users can be be a pioneer for the new era of patient data stewardship. Healthcare organizations can also pilot the Embleema health blockchain network as part of our Consortium at https://www.embleema.com/#consortium.

Global eHealth influencer and editor in chief of "Blockchain in Healthcare Today" John Halamka joins Embleema's advisory board. (https://en.wikipedia.org/wiki/John_Halamka)<br /> <br /> <br /> John D. Halamka, MD, MS, is Chief Information Officer of the of Beth Israel Deaconess Medical Center, former Associate Dean for Educational Technology at Harvard Medical School, Chairman of the New England Health Electronic Data Interchange Network (NEHEN), CEO of MA-Share, Chair of the Healthcare Information Technology Standards Panel (HITSP), Chief Information Officer of the Harvard Clinical Research Institute and a practicing Emergency Physician. <br /> <br /> <br /> As Chief Information Officer at CareGroup, he is responsible for all clinical, financial, administrative and academic information technology serving more than 3000 doctors, 12000 employees and one million patients. As Chief Information Officer and Associate Dean for Educational Technology at Harvard Medical School, he oversees all educational, research and administrative computing for 18000 faculty and 3000 students. As Chairman of NEHEN he oversees the administrative data exchange in Massachusetts. As CEO of MA-Share he oversees the clinical data exchange efforts in Massachusetts. As Chair of HITSP he coordinates the process of electronic standards harmonization among all the stakeholders nationwide.

Embleema signed a partnership with patient advocacy group CFTechnology.org. <br /> <br /> <br /> "A major concern of patients with Cystic Fibrosis is that their health data could be sold without their knowledge or consent. Clinical trial participants don't know where their data is going and it contains a huge amount of personal information beyond just their health records. Blockchain allows patients to share their data to aid in research - but on their terms and with full respect to their privacy. Our patient surveys have shown that 53% would agree to it if they had a proper way to give their consent to accelerating research. The Cystic Fibrosis community is a perfect model to pilot the Embleema technology." says Jeanne Barnett, Founder of CysticFibrosis.com and patient advocate for the Cystic Fibrosis community.

Pierre Fabre today announced it will join the Embleema Health Blockchain Consortium, which brings together patient advocacy groups, life sciences companies and healthcare providers inside a decentralized blockchain network where digital health data is shared by patients to monitor the safety and efficacy of new drugs in development.<br /> <br /> <br /> Embleema’s blockchain network offers a novel way to put patients at the center of clinical research by letting them own their health data, disrupting the slow, costly and opaque process by which low quality health data is currently collected by pharmaceutical companies to monitor the efficacy of new investigational drugs. For Pierre Fabre, blockchain is an opportunity to set a new standard of transparency and engagement in its relationship with patients and regulators, via real-time monitoring of the effects of new drugs, and compensating patients for their active involvement in clinical research.<br /> <br /> <br /> “The emergence of digital health is forcing the life sciences industry to move away from the current linear process of drug approval, where regulators make decisions based on paper-based reports which synthesize data collected years before publication, to a new iterative model where digital health data is shared in real-time between patients, life sciences companies and regulators,” said Frédéric Duchesne, CEO, Pierre Fabre Pharmaceuticals. “This means making the most of new technologies, to secure patient engagement, guarantee data integrity and ensure the safe transmission of data from patients to life sciences companies and regulators. Blockchain is the key to achieving this vision, and we chose Embleema because its technology platform was the most advanced.”<br /> <br /> <br /> Pierre Fabre will take part in building the decentralized Embleema Blockchain Network, hosting nodes to store and share data securely, and mining the network to guarantee the security of sensitive data. By design, the immutability of decentralized ledgers is particularly suited to safeguard the integrity of sensitive clinical data when shared from patients to researchers. It will offer the company a sandbox to interface its data with regulators as the industry moves toward tighter integration. <br /> <br /> <br /> The 21st Century Cures Act (2016) has given the FDA a mandate to accelerate regulatory approval for new treatments that incorporate the perspectives of patients and the reporting of real world data. The European Medicine Agency has a similar approach with its adaptive pathways. 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.<br /> <br /> <br /> Embleema aims to improve a process which is currently 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, which is typically required. Blockchain is disrupting this process by securing patient consent to share individual patient level data.<br /> <br /> <br /> Robert Chu, CEO of Embleema said: “We are delighted to have Pierre Fabre join our Health Blockchain Consortium and partner with them to bring patient engagement and evidence generation to the next level using Blockchain technology."<br /> <br /> <br /> About Pierre Fabre<br /> <br /> Laboratoires Pierre Fabre is a multinational pharmaceutical and cosmetics company founded in 1962 with a turnover exceeding $2Bn in 2017 and present in over 130 countries and with more than 10,000 employees. The company's business activity is focused on research, development, manufacturing and marketing of cosmetics, family health products and prescription medicines, with a focus on oncology.<br />

Working with specific patient advocacy groups and life science research, we are in the process of adapting our standard Dapp to customer and patient community specific pilots, for instance with the Cystic Fibrosis patient community.

As Embleema designs its decentralized marketplace, we are securing the buy-in of additional life sciences company wishing to define data infrastructure standards for next generation evidence generation, in monitoring in real-time the efficacy of new treatments.

As part of its decentralized Real-Workd Evidence marketplace, Embleema will allow decentralized exchange of healt data, with full opt-in control of patients, with relevant life science research.<br /> <br /> IP includes Marketplace Smart Contract