Dr. Kavita Lamror’s Post

As real-world data becomes increasingly accessible, regulatory and health technology assessment (#HTA) agencies are challenged to harmonize approaches to translate data into useful evidence for decisions. Electronic health records (#EHRs) are a growing source of real-world data. I was pleased to join world-leading experts in developing an EHR suitability checklist for researchers and provide recommendations for HTA agencies and policy makers to improve the use of EHRs for decision making.    The time is past for using one randomized controlled trial to make complex coverage and reimbursement decisions across heterogeneous populations. HTAs must continue to evolve to use the best-available evidence for decision making. EHR data provide a unique opportunity to efficiently extract aspects of the patient voice, treatment effectiveness, and preferences. The ISPOR Task Force Good Practices Report is a great place to start!

What could be more useful than this? ISPOR proposes a framework for assessing the suitability of electronic health records (EHRs) for use in HTAs. It sets international standards for HEOR, ensuring the data's reliability and relevance in healthcare decision-making. EHR is a rich source of RWD which can enhance the accuracy and relevance of HTAs. we all know this for years. Yet, surprisingly CDA/CADTH considers RWE as a "supplementary" part of the product dossier, and not crucial. It seems there is a gap in either trust or perception about RWD among public health authorities, while there is a huge pile of useful EHRs across the country. I understand the serious compliance concerns in granting access to these data, but there are now experienced solutions, enough science and international standards behind this. #RWE #EHR #CADTH

The SUITABILITY Checklist provides a framework for assessing the suitability of EHR data to address health technology assessments (HTA). The focus is on data delineation (the characteristics, provenance, and governance of data) and data fitness-for-purpose (the content, setting & time, and size & follow-up). The report serves both researchers in the conduct of evidence generation and HTA agencies and policy makers charged with the evaluation of HTA. There is something in here for everyone. Do we mention data linkage to close gaps in data? Do we discuss the need for validation? What about the utility of common data models and data quality standards? Thank you Rachael Fleurence, Ph.D. and Scott Ramsey for your leadership and the opportunity to provide insight to the Task Force.

On December 13, 2023, the U.S. Department of Health and Human Services (HHS) finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. Provisions in the rule advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information. Read more👇 ow.ly/18Pc50Qw4IQ #nursinginformatics #informaticsnews #nursingnews #healthtech

@ONC_HealthIT has released the final rule for Health Data, Technology, and Interoperability (#ONCHTI1). For a comprehensive analysis of key aspects from a #publichealth perspective read https://lnkd.in/eHNbuPAT

TEFCA, QHINS, and the Evolution of Health Data Utility with Michael Gagnon - Healthcare IT Today #TEFCA: The Trusted Exchange Framework and Common Agreement The Trusted Exchange Framework and Common Agreement (TEFCA) is a set of principles, terms, and conditions that aim to promote interoperability and data exchange across different health information networks. TEFCA establishes a nationwide health information exchange infrastructure, enabling the secure sharing of patient data among healthcare providers, payers, and patients themselves. It provides a standardized approach to data sharing, privacy, and security, ensuring that health information is protected while still being accessible to authorized parties. #TEFCA #interoperability #dataexchange #healthinformationexchange #QHINs: Qualified Health Information Networks Qualified Health Information Networks (QHINs) are organizations that meet specific criteria ai.mediformatica.com #health #healthcare #healthie #data #healthienevada #tefca #about #community #dataexchange #healthdata #healthdatautility #healthit #digitalhealth #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/3uhxYIb)

The health sector is one of the largest consumers of personal data due to the large volumes of data obtained and processed during a typical medical cycle, including registration, diagnosis, storage, analysis and transfer of data. The use of technology in processing of heath data has increased, with new and innovative methods of rendering health services through online means such as e-health and m-health heralding a new dawn in the health sector.   As part of our ongoing series on Data Protection, #ourveryown Deputy Managing Partner John Mbaluto, FCIArb and Senior Associate Morris Muriu analyse the Guidance Note issued by the Office of the Data Protection Commissioner on the processing of health data.   Read more here: https://rb.gy/1c4y1j   #dataprotection #healthdata #data #dataprivacyday

“We live in a world driven by data; therefore, why should the development of medicines be any different?" Kim Nørskov, Director of Product Management, Partisia Access to Danish health data is essential to inform a modern, data-driven healthcare system. Better access to health data is needed to support innovative clinical research, precision medicine and outcome-based pricing models. These advances can, in turn, lead to improved disease prevention and treatment, as well as better use of healthcare resources. The OSCAR project will contribute to the realisation of this potential through better access to Danish health data. DataFair. Partisia Enversion A/S https://lnkd.in/dfzngKX9

QThe Health Information Technology for Economic Clinical Health (HITECH) is one of several steps taken by the government to promote widespread implementation of health information technology (HIT). What other steps are being taken and what will be required for fully interoperable health information systems to become a reality?

This article (written with EUCOPE) focuses on three key elements for a successful and balanced use of (personal) health data such as research and innovation: Trade secrets safeguards - Data processing & transfers - Secondary use of health data EHDS opt-in/out. #EHDS #EUCOPE #TradeSecrets #HealthData