What is the history of electronic health records?
Results: By 1992, hardware had become more affordable, powerful, and compact and the use of personal computers, local area networks, and the Internet provided faster and easier access to medical information. EHRs were initially developed and used at academic medical facilities but since most have been replaced by large vendor EHRs.
What are the clinical benefits of electronic health record use?
Clinical benefits of electronic health record use: national findings Physicians reported EHR use enhanced patient care overall. Clinical benefits were most likely to be reported by physicians using EHRs meeting Meaningful Use criteria and longer EHR experience. Physicians reported EHR use enhanced patient care overall.
Are electronic healthcare databases useful for drug development and safety evaluation?
Please see: Objective Electronic healthcare databases (EHDs) are useful tools for drug development and safety evaluation but their heterogeneity of structure, validity and access across Europe complicates the conduct of multidatabase studies. In this paper, we provide insight into available EHDs to support regulatory decisions on medicines.
Is there a European Medicines Agency Review of post-authorisation studies for pharmacovigilance?
European Medicines Agency review of post-authorisation studies with implications for the European Network of centres for pharmacoepidemiology and pharmacovigilance. Pharmacoepidemiol Drug Saf 2011;20:1021–9. doi:10.1002/pds.2209 .
What is the current use of EHRs?
Current and new EHR technology will help to provide international standards for interoperable applications that use health, social, economic, behavioral, and environmental data to communicate, interpret, and act int ….
What is EHR technology?
Current and new EHR technology will help to provide international standards for interoperable applications that use health, social, economic, behavioral, and environmental data to communicate, interpret, and act intelligently upon complex healthcare information to foster precision medicine and a learning health system.
What are technical issues in EHR?
While EHR use has increased and clinicians are being prepared to practice in an EHR-mediated world, technical issues have been overshadowed by procedural, professional, social, political, and especially ethical issues as well as the need for compliance with standards and information security.
Do EHRs meet the needs of healthcare?
There have been enormous advancements that have taken place, but many of the early expectations for EHRs have not been realized and current EHRs still do not meet the needs of today's rapidly changing healthcare environment.
How many postauthorisation studies use EHDs?
The fact that between 30% and 50% of observational postauthorisation studies use EHDs as their main data source reflects the importance of these data sources to support regulatory decision-making. 1 9 On the other hand, the use of EHDs in preauthorisation research is currently limited and mostly focused on providing historical control data or understanding the natural history of the disease.
What is the role of the European Union in medicine regulation?
The European Union (EU) medicines regulatory network has responsibility for protecting patients by ensuring continuous evaluation of the safety of authorised medicines. At the core of such review is the scientific assessment of all available evidence including relevant information from the literature, results from non-clinical studies, randomised clinical trials, observational studies, spontaneous reports and results of other available research. A way to collect more information about a medicine’s safety postmarketing is by means of postauthorisation safety studies (PASS). 1 PASS may be imposed on a marketing authorisation holder by a regulatory authority or conducted by the company to address a safety concern or evaluate the effectiveness of risk-minimisation measures aimed at reducing the occurrence or severity of an adverse reaction. 2 3
How were EHDs identified?
Methods EHDs were identified from publicly available information from the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance resources database, textbooks and web-based searches. Databases were selected using criteria related to accessibility, longitudinal dimension, recording of exposure and outcomes, and generalisability. Extracted information was verified with the database owners.
Why are prescription only databases excluded?
Prescription-only databases were excluded because they cannot be used for aetiological studies in the absence of the outcome recording. Product-specific or disease-specific registries were considered out of scope as they create cohorts of patients whose entry is defined either by exposure to a product or by occurrence of a disease or health outcome. 25
How many databases are there for paediatric patients?
Patient age and gender were recorded in all data sources while paediatric patients were included in 32 databases (94%). The median year for database start was 1998, with the oldest database established in 1964 (the Finnish Hospital Discharge Register). The median calendar time covered by a database was 18.5 years (range 7–53 years). In terms of geographical coverage, 17% of databases collect data from Norway, 14% from Finland and 10% from Denmark and Italy ( figure 3 ).
What are the four categories of access to databases?
The accessibility of databases for research purposes was classified in four categories: no access, indirect access through the database owner or a third party, direct access restricted to specific datasets and direct access to the full dataset.
What is validation study?
For the purpose of this study, a validation study was defined as any study published in a peer-reviewed journal that aimed to validate the information available on an outcome or exposure in comparison with gold standard information, usually the patients’ original health records as reviewed by a medical professional or the same information captured by another database for a different purpose. For example, a study in 2012 compared cancer records in a general practitioners’ database, hospital records and cancer registries and found considerable discrepancies in cancer recording between these different data sources. 26
Abstract
Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role.
Introduction
We are currently on the edge of a golden era of medical understanding, with the amount of available information to support healthcare increasing at an enormous rate. Computer and information science concepts and tools are now part of the framework of biomedical science.
Obtaining data for clinical research processes
There are many different types of research questions and methodologies covered by the term ‘clinical research’. The pharmaceutical industry focuses in particular on controlled clinical trials.
Possibilities with new types of EHRs
What is now most commonly referred to as the EHR started to enter clinical care as early as the 1960s. It is interesting to note that many of the pioneers were already at that time seeing the improved possibilities for follow-up and research as one of the most valuable reasons for the transfer from paper-based to electronic recording systems.
Semantic challenges regarding the integration of EHRs
The analysis of EHRs for research, on a European scale, shares many challenges with the communication of EHRs between systems for patient care. Not only do EHR systems have markedly different repositories, the way clinical information organized within them by different teams and care settings is radically different.
Privacy: ethical and legal challenges to federated research
It is essential to use patients' medical information for secondary purposes, beyond care of the individual concerned, for the high quality of healthcare delivery and the effectiveness of scientific research 47. The use of EHRs for clinical research is inevitably challenged both by legal and ethical considerations 48.
Structural and political challenges
Given a growing healthcare demand and limited resources, health technologies must provide meaningful benefits to different stakeholders, such as improved health outcomes to patients and cost optimization to payers 77 - 79.