scholarly journals Ethical Considerations When Creating Evidence from Real World Digital Health Data

2020 ◽  
Author(s):  
C. Nebeker ◽  
Victoria Leavy ◽  
Eva Roitmann ◽  
Steven Steinhubl
Keyword(s):  
Data Sharing ◽  
Real World ◽  
Digital Health ◽  
Health Data ◽  
Personal Health ◽  
Real World Evidence ◽  
Self Study ◽  
Health Related Research ◽  
Health Related ◽  
English Speaking

AbstractBackgroundPersonal health data (PHD) are collected using digital self-tracking technologies and present opportunities to increase self-knowledge and, also biometric surveillance. PHD become “big” data and are used in health-related research studies. We surveyed consumers regarding expectations regarding consent and sharing of PHD for biomedical research.MethodsData sharing preferences were assessed via an 11-item survey. The survey link was emailed to 89539 English-speaking Withings product users. Responses were accepted for 5 weeks.Descriptive statistics were calculated using Excel and qualitative data were analyzed to provide additional context.ResultsNearly 1640 people or 5.7% of invitees responded representing 62 countries with 80% identifying as Caucasian, 75% male with 78% being college educated. The majority were agreeable to having their data shared with researchers to advance knowledge and improve health care.Participants responding to open ended items (N=247) appeared unaware that the company had access to their personal health data.ConclusionsWhile the majority of respondents were in favor of data sharing, individuals expressed concerns about the ability to de-identify data and associated risks of re-identification as well as an interest in having some control over the use of “their” data. Given consumer misconception about data ownership, access and use, efforts to increase transparency when interacting with individual digital health data must be prioritized. Moreover, the basic ethical principle of “respect for persons” demonstrated via the informed consent process will be critical in advancing the adoption of digital technologies that create real-world evidence and advance opportunities for N-of-1 self-study.

Health data sharing and use explored

Impact ◽  
2021 ◽  
Vol 2021 (8) ◽  
pp. 4-5
Author(s):  
Lucy Annette
Keyword(s):  
Data Sharing ◽  
Data Protection ◽  
Positive Impact ◽  
Digital Health ◽  
Health Data ◽  
Full Potential ◽  
Health And Wellness ◽  
Related Data ◽  
Health Related ◽  
The Right

Three expert roundtables took place as part of DigitalHealthEurope (DHE), with discussions surrounding health data sharing and use. In the first roundtable, the implementation of GDPR was explored and the experts delved into possible remaining challenges associated with understanding the way in which health related data may be used. Legal issues and the importance of data protection and citizen protection were discussed, as was the need for more human resources regarding data protection, which could be rectified by the provision of education in this area. The introduction of a new EU body responsible for data legislative needs was an idea that was put forward. Next, the law as an enabler of data use was discussed, along with the protection of citizens and data. It was highlighted that in order for the full potential of digital health to be realised, data literacy and skills are paramount. The experts also discussed how data can be used to protect citizens, without compromising a right to privacy, as well as the importance of generating the right data to ensure that it can be used to protect citizens' health and wellness. A further topic of discussion was how the development of a range of skills among data stakeholders would lead to the better use of data and that this would have a positive impact on health and wellness.

scholarly journals Connected Health User Willingness to Share Personal Health Data: Questionnaire Study

10.2196/14537 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14537 ◽  
Author(s):  
Maria Karampela ◽  
Sofia Ouhbi ◽  
Minna Isomursu
Keyword(s):  
Health Services ◽  
Data Sharing ◽  
Health Care Services ◽  
Digital Health ◽  
Scientific Research ◽  
Health Data ◽  
Personal Health ◽  
Online Questionnaire ◽  
General Data Protection Regulation ◽  
Connected Health

Background Connected health has created opportunities for leveraging health data to deliver preventive and personalized health care services. The increasing number of personal devices and advances in measurement technologies contribute to an exponential growth in digital health data. The practices for sharing data across the health ecosystem are evolving as there are more opportunities for using such data to deliver responsive health services. Objective The objective of this study was to explore user attitudes toward sharing personal health data (PHD). The study was executed within the first year after the implementation of the new General Data Protection Regulation (GDPR) legal framework. Methods The authors analyzed the results of an online questionnaire survey to explore the willingness of 8004 people using connected health services across four European countries to share their PHD and the conditions under which they would be willing to do so. Results Our findings indicate that the majority of users are willing to share their personal PHD for scientific research (1811/8004, 22.63%). Age, education level, and occupation of the participants, in addition to the level of digitalization in their country were found to be associated with data sharing attitudes. Conclusions Positive attitudes toward data sharing for scientific research can be perceived as an indication of trust established between users and academia. Nevertheless, the interpretation of data sharing attitudes is a complex process, related to and influenced by various factors.

scholarly journals Connected Health User Willingness to Share Personal Health Data: Questionnaire Study (Preprint)

2019 ◽  
Author(s):  
Maria Karampela ◽  
Sofia Ouhbi ◽  
Minna Isomursu
Keyword(s):  
Health Services ◽  
Data Sharing ◽  
Health Care Services ◽  
Digital Health ◽  
Scientific Research ◽  
Health Data ◽  
Personal Health ◽  
Online Questionnaire ◽  
General Data Protection Regulation ◽  
Connected Health

BACKGROUND Connected health has created opportunities for leveraging health data to deliver preventive and personalized health care services. The increasing number of personal devices and advances in measurement technologies contribute to an exponential growth in digital health data. The practices for sharing data across the health ecosystem are evolving as there are more opportunities for using such data to deliver responsive health services. OBJECTIVE The objective of this study was to explore user attitudes toward sharing personal health data (PHD). The study was executed within the first year after the implementation of the new General Data Protection Regulation (GDPR) legal framework. METHODS The authors analyzed the results of an online questionnaire survey to explore the willingness of 8004 people using connected health services across four European countries to share their PHD and the conditions under which they would be willing to do so. RESULTS Our findings indicate that the majority of users are willing to share their personal PHD for scientific research (1811/8004, 22.63%). Age, education level, and occupation of the participants, in addition to the level of digitalization in their country were found to be associated with data sharing attitudes. CONCLUSIONS Positive attitudes toward data sharing for scientific research can be perceived as an indication of trust established between users and academia. Nevertheless, the interpretation of data sharing attitudes is a complex process, related to and influenced by various factors.

scholarly journals Accelerating Health Data Sharing: A Solution Based on the Internet of Things and Distributed Ledger Technologies (Preprint)

2019 ◽  
Author(s):  
Xiaochen Zheng ◽  
Shengjing Sun ◽  
Raghava Rao Mukkamala ◽  
Ravi Vatrapu ◽  
Joaquín Ordieres-Meré
Keyword(s):  
Health Care ◽  
Internet Of Things ◽  
Data Sharing ◽  
Data Access ◽  
Health Data ◽  
Security And Privacy ◽  
Access Management ◽  
Related Data ◽  
Distributed Ledger ◽  
Health Related

BACKGROUND Huge amounts of health-related data are generated every moment with the rapid development of Internet of Things (IoT) and wearable technologies. These big health data contain great value and can bring benefit to all stakeholders in the health care ecosystem. Currently, most of these data are siloed and fragmented in different health care systems or public and private databases. It prevents the fulfillment of intelligent health care inspired by these big data. Security and privacy concerns and the lack of ensured authenticity trails of data bring even more obstacles to health data sharing. With a decentralized and consensus-driven nature, distributed ledger technologies (DLTs) provide reliable solutions such as blockchain, Ethereum, and IOTA Tangle to facilitate the health care data sharing. OBJECTIVE This study aimed to develop a health-related data sharing system by integrating IoT and DLT to enable secure, fee-less, tamper-resistant, highly-scalable, and granularly-controllable health data exchange, as well as build a prototype and conduct experiments to verify the feasibility of the proposed solution. METHODS The health-related data are generated by 2 types of IoT devices: wearable devices and stationary air quality sensors. The data sharing mechanism is enabled by IOTA’s distributed ledger, the Tangle, which is a directed acyclic graph. Masked Authenticated Messaging (MAM) is adopted to facilitate data communications among different parties. Merkle Hash Tree is used for data encryption and verification. RESULTS A prototype system was built according to the proposed solution. It uses a smartwatch and multiple air sensors as the sensing layer; a smartphone and a single-board computer (Raspberry Pi) as the gateway; and a local server for data publishing. The prototype was applied to the remote diagnosis of tremor disease. The results proved that the solution could enable costless data integrity and flexible access management during data sharing. CONCLUSIONS DLT integrated with IoT technologies could greatly improve the health-related data sharing. The proposed solution based on IOTA Tangle and MAM could overcome many challenges faced by other traditional blockchain-based solutions in terms of cost, efficiency, scalability, and flexibility in data access management. This study also showed the possibility of fully decentralized health data sharing by replacing the local server with edge computing devices.

scholarly journals Factors Related to Personal Health Data Sharing: Data Usefulness, Sensitivity and Anonymity

2021 ◽  
Author(s):  
Samar Helou ◽  
Victoria Abou-Khalil ◽  
Elie El Helou ◽  
Ken Kiyono
Keyword(s):  
Public Health ◽  
Data Sharing ◽  
Health Research ◽  
Online Survey ◽  
Public Health Research ◽  
Health Data ◽  
Perceived Usefulness ◽  
Personal Health ◽  
Sociodemographic Characteristics ◽  
Region Of Residence

Using an online survey, we examined the relationships between the perceived usefulness, sensitivity, and anonymity of personal health data and people’s willingness to share it with researchers. An analysis of 112 responses showed that people’s willingness and perceptions are related to the type of the data, their trust in the data’s anonymity, and their personal sociodemographic characteristics. In general, we found that people do not completely trust that their identities remain anonymous when sharing data anonymously with researchers. We also found that they are more willing to share personal health data with researchers if they perceive it as useful for public health research, not sensitive, and if they trust that their identity will remain anonymous after sharing it. We also found that people’s age, gender, occupation, and region of residence may be related to their perceptions regarding the sharing of personal health data.

scholarly journals Real world evidence in cardiovascular medicine: ensuring data validity in electronic health record-based studies

2019 ◽  
Vol 26 (11) ◽  
pp. 1189-1194 ◽  
Author(s):  
Tina Hernandez-Boussard ◽  
Keri L Monda ◽  
Blai Coll Crespo ◽  
Dan Riskin
Keyword(s):  
Real World ◽  
Digital Health ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Cardiovascular Medicine ◽  
Real World Data ◽  
Chi Square ◽  
Regulatory Decision ◽  
Real World Evidence ◽  
Electronic Health

Abstract Objective With growing availability of digital health data and technology, health-related studies are increasingly augmented or implemented using real world data (RWD). Recent federal initiatives promote the use of RWD to make clinical assertions that influence regulatory decision-making. Our objective was to determine whether traditional real world evidence (RWE) techniques in cardiovascular medicine achieve accuracy sufficient for credible clinical assertions, also known as “regulatory-grade” RWE. Design Retrospective observational study using electronic health records (EHR), 2010–2016. Methods A predefined set of clinical concepts was extracted from EHR structured (EHR-S) and unstructured (EHR-U) data using traditional query techniques and artificial intelligence (AI) technologies, respectively. Performance was evaluated against manually annotated cohorts using standard metrics. Accuracy was compared to pre-defined criteria for regulatory-grade. Differences in accuracy were compared using Chi-square test. Results The dataset included 10 840 clinical notes. Individual concept occurrence ranged from 194 for coronary artery bypass graft to 4502 for diabetes mellitus. In EHR-S, average recall and precision were 51.7% and 98.3%, respectively and 95.5% and 95.3% in EHR-U, respectively. For each clinical concept, EHR-S accuracy was below regulatory-grade, while EHR-U met or exceeded criteria, with the exception of medications. Conclusions Identifying an appropriate RWE approach is dependent on cohorts studied and accuracy required. In this study, recall varied greatly between EHR-S and EHR-U. Overall, EHR-S did not meet regulatory grade criteria, while EHR-U did. These results suggest that recall should be routinely measured in EHR-based studes intended for regulatory use. Furthermore, advanced data and technologies may be required to achieve regulatory grade results.

scholarly journals The Policy Effect of the General Data Protection Regulation (GDPR) on the Digital Public Health Sector in the European Union: An Empirical Investigation

2019 ◽  
Vol 16 (6) ◽  
pp. 1070 ◽  
Author(s):  
Bocong Yuan ◽  
Jiannan Li
Keyword(s):  
European Union ◽  
Financial Performance ◽  
Data Protection ◽  
Digital Health ◽  
Rapid Development ◽  
Health Data ◽  
Personal Health ◽  
The European Union ◽  
General Data Protection Regulation ◽  
General Data

The rapid development of digital health poses a critical challenge to the personal health data protection of patients. The European Union General Data Protection Regulation (EU GDPR) works in this context; it was passed in April 2016 and came into force in May 2018 across the European Union. This study is the first attempt to test the effectiveness of this legal reform for personal health data protection. Using the difference-in-difference (DID) approach, this study empirically examines the policy influence of the GDPR on the financial performance of hospitals across the European Union. Results show that hospitals with the digital health service suffered from financial distress after the GDPR was published in 2016. This reveals that during the transition period (2016–2018), hospitals across the European Union indeed made costly adjustments to meet the requirements of personal health data protection introduced by this new regulation, and thus inevitably suffered a policy shock to their financial performance in the short term. The implementation of GDPR may have achieved preliminary success.

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