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The post Protected: More pertinent than ever during and post- COVID-19 pandemic: Accord Health Care launches Unify Health: privacy-by-design, seamless to use cancer patients’ app appeared first on Pryv.

EREBOTS enable the configuration and deployment of personalized chatbots to support users in multi-topic and multi-campaign behavioral change programs with full respect to data privacy. Conversational agents coaching people fighting chronic diseases, addictions, and other health issues, leading to decreased life quality are among EREBOTS applications. 

Healthcare and eHealth systems are facing the strain of a significant demand for user (patient) empowerment—implying the need for new logics, architectures, dynamics, and interfaces 

Siri, Alexa and Cortana are among the best known intelligent systems that  have the ability to assist humans through multimodal interactions, including text, buttons, vocal, video, and gesture-based communication. Although such virtual assistants heavily rely on vocal interactions, sometimes more discrete and asynchronous chat-like communications are still preferred. Chatbots are an example of intelligent systems relying on interactions mostly menu/text-based. Anywhere/anytime availability, immediate response, confidentiality, social acceptance, and massive scalability are among the factors contributing to the increasing and an effective adoption of chatbots in a wide range of domains, particularly for motivational such as for social network campaigns and support, customer management, eHealth and assisted-living scenarios. In the healthcare domain, chatbots leveraging on tailored support and social aspects can be of great support to foster behavioural change, monitoring of chronic health conditions and primary care to name a few. 

However, most of the modern chatbots rely on state machines (implementing conversational rules) and one-fits-all approaches, neglecting personalization, data-stream privacy management, multi-topic management/interconnection, and multimodal interactions. This leads to significant limitations in inadequate personalization, lack of real-time monitoring, reporting and customization for medical personnel, lack of mechanisms to integrate communities of chatbots, limited knowledge sharing capabilities, and the impossibility of seamlessly deploying multi-domain campaigns within the same framework.  These limitations are linked to the predominantly rigid architectures proposed in most existing approaches. Most chatbot solutions rely on monolithic and centralized data management strategies, making it hard to comply with privacy regulations such as GDPR, Swiss DPA. The sensitive nature of data collected through chatbot interactions makes it necessary to shift the control of personal data towards the users themselves, empowering them in the process.  EREBOTS uses an instance of Pryv to persist the user’s chat history and all personal data. Employing Pryv, users gain exclusive control of their data, thus being able to revoke the consent at any point, disabling EREBOT access to it, and, if necessary, fully removing any stored piece of information.

Meet EREBOTS:

• Multi-scenario agent-based chatbot framework: In EREBOTS, it is possible to combine several context-dependent behaviors that can be encapsulated in dedicated story lines, which can be modeled as isolated or interconnected scenarios. These behaviors are enacted by a network of user agents, doctor agents, and orchestrated through gateway agents.
• User personalization: User agents build a model of the user profile, his/her preferences, history, goals, and aggregated information. With this model, the user agents are able to tailor behaviors and provide a personalized experience.
• Healthcare personnel control and monitoring: Medical doctors and healthcare providers have the possibility of defining possible goals, configure self-assessment interactions, or customize the types of activities proposed to patients/participants. Moreover, they can monitor users’ profiles with detailed analytics describing their behaviors and aggregated trends.
• Privacy and ethics compliance: In EREBOTS, all the sensitive/personal information are solely under the control of the user, who can make any decisions concerning storage and sharing of her information. Through the Pryv.io platform integrated into EREBOTS, users may configure fine-grained access control or even entirely remove their data if they decide so.
• Multi-campaign implementation and testing: EREBOTS has been employed and tested in scenarios such as smoking cessation and balance enhancement exercises (physical rehabilitation) for older adults during social confinement (due to COVID-19 restrictions).

EREBOTS proves that assistive agents can interact with each other in the back-end: 

• opening the door to knowledge sharing for campaign-related investigations

• Allowing medical personnel to access real-time aggregated and personal information of the individuals participating in a given campaign
• Enabling multimodel knowledge representation which can be enabled for simultaneous campaign executions, 
• Fine-tuning data-/action-driven personalization strategies
• Allowing users to be monitored via direct feedback collection
• (Re)defining online therapies and campaigns story lines
• By using the the data schema defined as Pryv streams typically serialized in JSON and possibly exposed using semantically rich representations (e.g., HL7 FHIR—ongoing work in EREBOTS); 
• Proposing (pro)active mechanisms that  can be tailored to a specific case study
• Storing users’ data in a stream-based privacy-compliant system solely managed by the user.

Source: https://www.mdpi.com/2079-9292/10/6/666/htm

About the eHealth unit of the Institute Information Systems HES-SO Valais-Wallis

The eHealth unit is part of the Institute of Information Systems of the University of Applied Sciences and Arts Western Switzerland (HES-SO). Based in Sierre (Valais, Switzerland), the eHealth unit undertakes applied research in close collaboration with public or private companies and institutions. It has gained solid experience with complex interdisciplinary projects related to digital health, at national and international levels. The eHealth unit has for instance invested many research efforts in the development of sensor-based mHealth applications for chronic diseases (e.g. diabetes type 1 and 2). Furthermore, the unit has developed expertise in health record data interchange and the usage of standards (HL7, FHIR), as well as the development of privacy and anonymity preserving algorithms for health data exchange (Nano-Tera.ch ISyPeM2 project). It is also working on blockchain-based healthcare data management and on a prototype of a framework for managing and sharing EMR data for cancer patient care. It is investing many efforts in personalized health support, such as for coaching in physiotherapy, or smoking cessation programs run on social networks with chatbot supports.

About Pryv

Pryv makes essential software for data-driven healthcare innovation. Our purpose-built middleware helps organizations manage personal data from creation to use, sharing and disposal. We accelerate time to market, cut IT development costs and speed up connectivity to all data sources. Pryv addresses the enhanced citizen’s right under GDPR and turns privacy compliance into a competitive advantage. For more information: https://pryv.github.io/www

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If traditional clinical trials were already on the spot for a digital upgrade, the pandemic/lockdown situation made it now a top priority for the global healthcare industry. Especially, if researchers want to pursue their studies while keeping participants safe at home, they have to go digital and adopt eConsent.

Yet, what can be easily done when meeting in real life can be difficult to achieve technically. This is especially true for consent. 

Consent under trials

“Informed consent” is the solid basis for any clinical trial. That is, the consent that an investigator must obtain prior to any experiment on a participant. Within the EU, this process is governed by the Clinical Trials Directive, soon to be replaced by the Clinical Trials Regulation (CTR).

According to the Directive, “informed consent” shall be defined as follow: “decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent”. As for the CTR, it provides us with a similar definition: “informed consent means a subject’s free and voluntary expression of his or her willingness to participate in a par­ticular clinical trial, after having been informed of all aspects of the clinical trial that are relevant to the subject’s decision to participate”, and also adds that “informed consent shall be written, dated and signed”.

Thus, in order to enrol participants in a clinical trial, investigators must obtain their consent first, and are obliged by the law to provide them with all relevant information. We certainly all can picture how it would look like when an investigator and a participant meet in real life. The participant will come where the study takes place. Shake hands with the person in charge. See with his eyes how everything happens. And then they will talk. 

At some point, some paperwork will be involved, and all the processes will be documented as it is required by the law. The participant will then be left with the choice to consent or not.

Now how do you implement that virtually? This is where eConsent solutions come in.

eConsent

Electronic consent (eConsent) is the virtual equivalent of consent. So instead of having  people meeting each other in order to exchange information and sign a piece of paper, everything is done remotely. Which is exactly what we need in a time of a pandemic disruption, and also to increase the potential and success of clinical trials in general, as it would open infinite possibilities for real world data collection and worldwide participants recruitments.

eConsent allows patients to continue consenting and enrolling in clinical trials when not being able to present in person, whether due to an isolation, physical condition or geographic location. 

However, contrary to popular belief, eConsent is way more than a “checking a box” option – especially within the context of a clinical trial.

Even virtually, the law applies and obliges investigators to inform the participants, document everything, and so on. But more importantly, if you are looking to enroll participants into a decentralized and remote clinical trial, you will have to build a digital trust. 

Solution: Pryv.io Privacy & eConsent Solution to build trust for your remote clinical trial.

Building a digital trust is the key to unlocking the difficulties of remote recruitment. When running a digital trial, you have to keep in mind that basically, you are asking people that you’ve never met to consent that you experiment on them. That certainly doesn’t bring much confidence.

So be innovative, adopt technology, provide more value. Just because you “have to” go digital doesn’t mean that you can not take this as an opportunity to push back the barriers and overcome the limitations of the current traditional on-site paper-based clinical trials.

Make a call. Use telehealth solutions to meet virtually. Build a virtual path to follow that will put your participants in the same situation that they would be if they would come to meet you.

Now how can we help you? Companies can deploy Pryv.io as a foundation for their digital clinical trials. Our software is specifically engineered to empower CRO and Pharma organizations to design and run decentralized, remote and patient-centric clinical trials.

While you focus on designing the perfect user interface for your patients, we provide you with a data management platform ready to welcome unlimited types of data from unlimited devices. So you can use IoT, medical devices and wearables to capture real-world data at any time, enabling you to unleash new discoveries during your trial.

We don’t access or host any data. You and your participants can even choose in which country you want the data to be stored – our platform is specifically designed to run multi-centric clinical trials at ease. Once stored, the data will be kept per-user, so you can easily show each participant his trial dataset and engage them in the process, sending a strong message of transparency and inclusivity.

Our Pryv.io platform also comes with eConsent and auditing tools so you can rapidly cook-up your own digital informed consent in compliance with CTR and GDPR. Our eConsent mechanism will allow you to keep track of every consent and related data-access per participant, while our audit solution will enable you to document the full process and retrace every access to the data.

Stephanie & Evelina @Pryv.

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• Spreading Adoption of Telehealth Solutions
• Fostering eConsent Acceptance
• Leveraging Real World Evidence Data
• Reporting Patient Outcomes

Swiss-made Pryv.io is a ready-to-use personal data lifecycle management software, specifically engineered to empower CRO and Pharma organizations to design and run decentralized, remote and direct-to-patient clinical trials.

• Trials are executed through tele-healthcare, i.e. conducted remotely with participants staying at home.
• Patients can give their consent remotely (eConsent).
• Physician visits can be done remotely (telemedicine).
• Data can be captured remotely via digital biomarkers (medical devices, wearables, apps).
• Real-World Data can be captured (geolocation, environmental exposure such as temperature, sun, humidity, and allergens).
• Lifestyle data can be integrated (nutrition, sleep, stress…).
• Multi-centric clinical trials are conducted where data is stored in different locations.
• Full compliance is respected in terms of data lifecycle management, patient rights, user access control and audit.

“Our platform will not only capture patient data but will also give participants a view on their own trial dataset, sending a strong message of transparency and inclusivity, which can truly engage them.”

Pierre-Mikael Legris, CEO Pryv SA

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Switzerland, Morges, 12 June 2019 – Pryv, the leading Swiss provider of privacy and personal data management software, and BGO Software, a Bulgaria-based leading software services and product development company, have announced the launch of an innovative eCRF solution to manage Real-World Data (RWD) and informed electronic consent (eConsent).

Designed to meet the requirements of GDPR and HIPAA regulations, the eCRF solution is based on Pryv.io middleware and BGO Software’s Metaforms software. Among the key functionalities of the solution is its ability to dynamically capture and store patients’ informed eConsent. To ensure trust and compliance, a full audit trail documenting interaction with the data is embedded in the solution.

The web-based form-building software allows researchers and clinicians to capture patients’ RWD and pave the way to useable insights . This data includes information from complex forms, questionnaires, voice input, wearable devices, mobile health (mHealth) apps, electronic patient-reported outcomes (ePRO), environment and more.

RWD is considered to be a major source of valuable information from patients in real-world conditions. Capturing RWD improves personalized patient care and enables more efficient scientific and clinical research. Additionally, this data makes it possible to monitor a patient’s safety and evaluate risk, demonstrate efficacy and effectiveness, gain market access and address the public’s growing interest in an efficient and sustainable healthcare system.

“Real-World Data is undoubtedly a valuable asset. However, creating and integrating dynamic forms and complying with regulations can be a very complex task and requires specific knowledge,” said Ivailo Ivanov, CTO of BGO Software. “Collaborating with Pryv adds an additional layer to the management of clinical data in our product Metaforms and ensures the patient’s data remains private. This is vital to ensuring they feel confident in sharing their data and giving us access to RWD.”

Though the software architecture of an mHealth application is important to ensuring the successful implementation and usage of the solution, this is only one part. A user-friendly design is more than just aesthetics. It plays a crucial role in the patient’s engagement, the operational efficiency, and the overall management of clinical data.

“A regulatory-compliant eCRF solution is one of the most common requests we receive from customers,” said Pierre-Mikael Legris, CEO of Pryv. “A user-friendly design is the key to collecting enriched RWD. By using BGO’s clinical data management experience and engineering know-how, we have been able to create an easy-to-use, modern and intuitive end-to-end solution that captures RWD and manages dynamic eConsent.”

The Pryv/BGO eCRF RWD solution can be accessed anywhere and can be customized to fit the needs and processes of any business or organization. Its functionalities benefit multicenter clinical trials. An API for third-party integrations has been made available to optimize data collection and real-time sharing. The solution is easily adopted and can be quickly launched – a transition to a paperless process is possible within a few weeks and the solution can be deployed on site or over the cloud.

Contact us to book eCRF / RWD platform demo 

About Pryv

Pryv helps organisations manage personal data from creation, use and sharing as well as address the enhanced data subject rights under GDPR such as transparency, portability and right-to-be-forgotten. Packaged for rapid integration, the software solution comes with a turnkey IoT connectivity, secure storage vault, fine-grained consent management and comprehensive auditing capability that radically cut IT development costs and accelerate time-to-benefit while addressing most stringent data protection requirements.

About BGO

BGO designs and develops solutions that help and support a number of governmental institutions, enterprises and IT organizations globally and has considerable expertise, primarily in healthcare, pharmaceutical and the clinical research industry. The company facilitates the work of, researchers, clinicians, CROs, biotechnology experts, trial managers, trial investigators, coordinators and other industry administrative professionals. BGO Software is an official Microsoft Gold Partner, Specialized supplier for manufacturing of IT of Hoffmann-La Roche and Genentech, Official Government Supplier for the Health Research Authority of the Department of Health in the United Kingdom &  Progress Premier Partner.

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The collaboration includes the development of an innovative clinical data management solution providing a comprehensive picture of each patient’s journey – one which combines patient reported outcome (PRO) data with clinical records collected by healthcare professionals. The platform is designed to meet the unique needs of the investigational research as well as the post approval market, including phase IV studies, registries and online medical communities.

“Patient relevant outcome measures are a proven necessity to assess the efficiency, effectiveness and personalization of clinical trials” said Samir Mechati, CEO at RodanoTech “It supplements existing clinical data, increases treatment adherence and provides important insight about how patients are doing between medical visits”.

The patient data set is expanding from the high-quality information collected in the clinical protocol to the more private data collated from wearables, mobile apps and in-home clinical devices. By streamlining the collection and integration of this dataset, the joint Pryv/RodanoTech solution ensures a real-time connection with the patient health – capturing insightful data measured and influenced outside the four walls of the clinical setting.

“Real time, real world data that can be captured in patients’ daily lives is a powerful tool to optimise clinical research” said Pierre-Mikael Legris CEO at Pryv “Our platform will not only capture patient data but will also give participants a view on their own trial dataset, sending a strong message of transparency and inclusivity which can turn them truly engaged”.

Patient consent is a critical process that has historically been highly inefficient and prone to error. The joint Pryv/RodanoTech platform optimises that additional level of security between participants and clinical trial sites. Its greatest value comes from its dynamic, fine-grained consent and re-consent capability which gives patients the trust, transparency and control they require from clinical trials. The platform logs all authorizations, including the ‘contract’ between the patient and the investigator, for compliance oversight as mandated by GCP guidelines and privacy regulations.

RodanoTech and Pryv offer tailored solutions to conduct projects of any size, from small Phase I studies to large scale trials involving sophisticated designs and long-term follow-up across clinical settings and geographies. Our Academic offer begins with a “get started” costing for proof of principles and goes to a premium packaged solution for large scale clinical trials.

Contact us to discover the power of a tailor-made platform combining clinical and patient health data and supported by leading experts with extensive experience in clinical development.

About Pryv
Pryv helps organisations manage personal data from creation, to use and sharing as well as address the enhanced data subject rights under GDPR such as transparency, portability and right-to-be-forgotten. Packaged for rapid integration, the software solution comes with a turnkey IoT connectivity, secure storage vault, fine-grained consent management and comprehensive auditing capability that radically cut IT development costs and accelerate time-to-benefit while addressing most stringent data protection requirements.

About RodanoTech
RodanoTech is specialised in clinical data management services and electronic data capture solutions for industry and academic projects. The RODANO platform is the underlying proprietary technology that powers all RodanoTech solutions. RODANO is based on the most recent technical standards to streamline all aspects of the study conduct and complies with the latest recommendations regarding the use of computerized systems in clinical investigations (21 CFR Part 11). The platform can scale and adjust to accommodate clinical trial complexities through systematic automation of repeatable processes while providing appropriate hooks to new data collection methods.

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Lausanne, June. 15, 2018 — Pryv, the leading provider of privacy and personal data management software, announces that it has signed a partnership agreement with Altran, the leader in Engineering and R&D services empowering the next generation of healthcare evolution.

This partnership puts the patients at the heart of MedTech innovation and protects their privacy complying the most stringent data regulations with Altran acting as an end-to-end R&D engineering partner developing smart, patient-centric and compliant medical devices. Pryv brings trust, transparency and control over the use of sensitive medical data.

“Medtech companies operate in one of world’s most regulated environments, and scrutiny and complexity are only increasing” says Andreas Kuhn, CTO at Altran Switzerland. “Pryv extends our regulatory expertise with a rigorous data protection capability that accelerate time to compliance and enable privacy-preserving design from the outset of product development”

Altran and Pryv teamed up to enable Riva Digital, a Swiss eHealth initiative tackling the problem of hypertension in Switzerland.

The initiative encourages citizens to maintain healthy lifestyle behaviors and instantly keep tab on their blood pressure level right from their smartphone.

The medical-grade monitoring app builds on a breakthrough optical blood pressure monitoring method from the Swiss Center for Electronics and Microtechnology (CSEM), App development and integration from Altran and rigorous privacy and personal data management capability from Pryv. 

Riva digital bets that one year from now 100,000 people will have demonstrably lowered their blood pressure.

Pryv helps organisations manage personal data from creation, to use, to sharing and enhanced rights such as portability and right-to-be-forgotten. Packaged for rapid integration, the software solution comes with a secure storage vault, encryption protocols, fine-grained consent management and comprehensive auditing capability that radically cut IT development costs and accelerate time-to-benefit while addressing most stringent data protection requirements.

Altran ranks as the undisputed global leader in Engineering and R&D services (ER&D), following its acquisition of Aricent. The company offers clients an unmatched value proposition to address their transformation and innovation needs. Altran works alongside its clients, from initial concept through industrialization, to invent the products and services of tomorrow. For over 30 years, the company has provided expertise in aerospace, automotive, defense, energy, finance, life sciences, railway and telecommunications The Altran Group generated revenues of €2.9 billion in 2017, with some 45,000 employees in more than 30 countries.

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