CLINICAL RESEARCH INFORMATICS CONSULTING

The integrity, compliance, and re-use of healthcare data.
Harnett Online can support a critical role in improving clinical research and compliance. Prioritization of collaboration, data-driven insights, and sustainable strategies ensure meaningful results. By providing expert guidance and support, Harnett Online can help organizations navigate complex regulations and ensure that the use of research data is conducted ethically and in accordance with industry standards.

From developing protocols, processes, and procedures to training staff and conducting audits, consulting services can help organizations improve their research practices and maintain compliance.
...Clinical data from electronic health records is now leveraged for everything from research recruitment to outcomes analysis and geocoding to genetics. How to acquire it requires an understanding of the rules. The technical ecosystem of healthcare industry has changed. The financial crisis in 07-08 was a global economic downturn sometimes compared to the Great Depression. In the year that followed, the U.S. government passed a spending bill outlining the American Recovery and Reinvestment Act of 2009 (ARRA) often referred to as the "stimulus package". ARRA was crafted to spur the economy, invest in infrastructure, enhance healthcare, and other fiscal needs. At the time, implementation of electronic health records (EHRs) started accelerating. ARRA underscored the investments by hospitals and clinical practices with the Health Information Technology for Economic and Clinical Health (HITECH) Act. The total cost for ARRA is outside the scope of this statement, but the HITECH Act provided ~$35 billion to promote the adoption of health information technology, particularly EHRs. Of this amount, approximately $26 billion was specifically designated for Medicare and Medicaid that aimed to incentivize healthcare providers to adopt and properly use EHR systems. Through the program called “Meaningful Use”, the government basically subsidized part of the cost of installing and using EHRs. The remaining funds were allocated to various other initiatives such as development of health information exchanges, workforce training, enhanced privacy, and compliance. In the past 15+ years, EHRs have been universally adopted that represents a massive source of valuable data. When affectively collected and harvested, these data offer significant advantages by improving patient care, enhancing operational efficiency, supporting informed decision-making, monitoring public health, improving quality and safety, engaging patients, managing population health, facilitating interoperability, advancing research, and ensuring compliance. Healthcare data, when appropriately integrated with non-clinical data such as geographic encoding, is driving newer concepts called social determinants of health that are focused on population health and welfare. Even unstructured data such as clinical notes are becoming minable to derive computable phenotypes. Recent standards such as HL7 Fast Healthcare Interoperability Resources (FHIR) facilitate universal data exchange between data silos using standardized clinical terminology and ubiquitous web technology, that is, Application Programming Interfaces (APIs). Artificial intelligence and machine learning algorithms are redefining how we (hopefully) appropriately and best use these technologies for healthcare data to gain new insights. Furthermore, cloud-based storage and computing power have begun to leverage vast, centralized datastores which is of particular interest to the National Institutes of Health (NIH). EHRs and their rich data repositories are big business. Optimize clinical research and compliance with proven expert informatics engagement. My experience combines knowledge with technology to streamline clinical data liquidity, ensure compliance, and accelerate discovery. Singular but multidimensional, Harnett Online provides solutions and perspective that empower informed decisions supported by an experiential and academic framework.
How We Can Help
Harnett Online has skills very specific to clinical research in academic settings. Unlike corporate environments where resources abound, universities face financial constraints where efficiencies, cultural issues, and organizational assets need to be leveraged.
Operations
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Grant writing of technical content (interpretable by review committees)
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Protocol development and system review (clinical studies)
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Intellectual property R&D / commercialization (UC 1819 Innovation Hub)
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NIH & SBIR/STTR grant submissions
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Informatics Education (academic credentialing to course development and instructing)
Compliance
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Human Subjects research protection (Institutional Review/Privacy Board)
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HIPAA Compliance (protection and proper use of research data - e.g. recruitment)
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Audit of use of Electronic Health Record (EHR) data for academic research
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Root cause analysis and corrective action plans
Technology
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EHR data access through established channels
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Electronic Data Capture (EDC) for research including de-identification
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Application of HL7 Fast Healthcare Interoperability Resources (FHIR)
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Research registry development
Analysis
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Real World Data outcomes analysis (TriNetX Research Network)
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NIH FAIR principles assessment
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Policy & Procedure reviews
Quick ID
Harnett Online LLC
Brett M Harnett
Professor Emeritus
University of Cincinnati
College of Medicine
www.linkedin.com/in/brett-harnett
@thebrettski
harnett.com