Disease-specific electronic health record (EHR) solutions are evolving rapidly and allow clinicians and healthcare workers to realize the benefits of health information technology (HIT). In this inaugural issue of HIV Clinical Interfaces, we spoke with Mr. David Rebey, Head of US Business Operations, Janssen Diagnostics, Inc. on the emergence of EHRs for the HIV treatment community.
Janssen Diagnostics, Inc. has a long-standing commitment to the HIV treatment community. Approximately 5 years ago, we conducted pilot programs to deliver current and historical vircoTYPE™ HIV–1 results electronically into LAB TRACKER™ with the goal of providing our clients who used Janssen Diagnostics, Inc. resistance products with a longitudinal view of resistance patterns.* During this same timeframe, we realized that the HIV epidemic was changing, in that patients were living longer on modern regimens with fewer treatment failures as had been seen in the past. These developments underscored the challenges of managing HIV as a complex, chronic disease and the emerging need to look at the entire patient on a longitudinal basis. To this end, Janssen Diagnostics, Inc. realized that entry into HIT was a natural evolution of our past experiences in the HIV field. We have a long legacy of working with clinical outcomes data, diagnostic measures, and HIV that makes us well poised to serve HIT and needs of the HIV treatment community.
In our discussions with the HIV treatment community and initial research of the HIT market, we found that there are numerous EHR solutions available. However, most EHR solutions were focused on general-purpose healthcare and lacked disease-specific functionality. It became apparent that there is an emerging need in the HIT market to build customized EHR solutions designed for healthcare professionals who care for patients with specific complex diseases like HIV/AIDS.
Many available EHR solutions can store data and assist the healthcare provider with routine clinical practice. However, accessing and using data can be challenging with many EHR solutions, oftentimes requiring support from a site’s Information Technology (IT) department or EHR manufacturer to submit data queries or retrieve reports.
Drawing on our established experience in HIV disease, Janssen Diagnostics, Inc. believes that there are a number of additional opportunities for applying information stored in an EHR solution. For example, HIV healthcare providers will be interested in not only inputting clinical data, but also extracting data and querying their patient population databases to assess how specific subsets are responding to therapy, examine trends, test hypotheses, as well as create reports to meet State and Federal reporting requirements (eg, Ryan White CARE Act, HIVQUAL). It’s all about providing secure access to use data in more than routine clinical ways. By putting these data to work, we believe there is an opportunity to improve the care of people living with HIV/AIDS.
AVIGA™ is a Drummond-certified™ (EHR Modular), web-based (SaaS), EHR solution that was designed by Janssen Diagnostics, Inc. in collaboration with HIV specialists. One of Janssen Diagnostics, Inc.'s objectives when designing AVIGA™ was to build a system that made it easy for healthcare providers to create custom queries and research questions of their individual patient populations directly from the desktop without the need for IT support. For example, AVIGA™ makes it easy for healthcare providers to look at all of their patients on a particular drug regimen and concurrent conditions that may have arisen before or after initiation of that treatment. Although not definitive clinical evidence, awareness of such trends can assist the healthcare provider to formulate hypotheses on what is happening in patients on a particular therapy. This is just one example of the HIV-disease-specific functionality of AVIGA™ to catalogue patient data, research custom queries, and create reports.
During the development of AVIGA™, Janssen Diagnostics, Inc. understood that there were many clinical sites that were part of a larger institution or enterprise where the use of another EHR solution was mandated for the entire medical system. However, we also recognized that such EHR solutions were not meeting the HIT needs of the HIV treatment community. To this end, Janssen Diagnostics, Inc. has developed and will offer the web-based AVIGA REPORTER™ as an HIV-specific data reporting and querying tool that could be added on or integrated with another EHR solution. AVIGA REPORTER™ interfaces with other commercial EHRs and software applications, specifically capturing and configuring medical information necessary for HIV reporting and research.
Part of the American Recovery and Reinvestment Act (ARRA) of 2009 (commonly referred to as the “Stimulus” or “Recovery Act”), the Health Information Technology for Economic and Clinical Health (HITECH) Act promotes the adoption and use of healthcare information technologies (HIT), including electronic health record (EHR) solutions. The federal government has authorized $19 billion in incentives for healthcare professionals to adopt and use HIT in a meaningful way.1
Incentive payments are tied to demonstrating Meaningful Use (MU) of EHRs. MU guidelines are being released in stages, with the intent of striking a balance between the urgency of adopting EHRs to improve our healthcare system and recognizing the challenges that adoption will pose to healthcare providers.1,2
To qualify for MU, a total of 20 MU criteria need to be met. This includes 15 core objectives outlined in the HITECH act that health professionals must adopt, install, and use. Moreover, users must select or defer 5 additional MU criteria from another set “menu” of 10 objectives.
The core objectives comprise basic functions that enable EHRs to support healthcare and improve the safety, quality, and efficiency of care. The menu of 10 additional criteria includes the ability to perform drug-formulary checks, incorporate clinical laboratory results into EHRs, provide reminders to patients for needed care, identify and provide patient-specific health education resources, and employ EHRs to support transitions between care settings and personnel.
To learn more about MU and EHR incentive plans, please visit:
Mr. Brian Wasikowski, Director of HIT Alliances and Customer Support at Janssen Diagnostics, Inc. provides insights on Ryan White CARE Act functionality in AVIGA™ and AVIGA REPORTER™.
One of the major challenges associated with generating required reports for the Ryan White CARE Act is data-entry burden. The CAREWare program provided by the Health Resources and Services Administration (US Department of Health and Human Services) is free, scalable software to assist in producing the Ryan White HIV/AIDS Program Services Report (RSR). CAREWare is not an EHR designed for clinical use, but rather a reporting tool. Although CAREWare can be modified to allow for the electronic transfer of patient data from an EHR, this often requires significant IT support, programming, and cost. Many smaller sites or practices are not able to afford this level of IT support and oftentimes rely on existing or additional staff to manually enter RSR-required patient data from existing electronic or paper files.
AVIGA™ is a web-based EHR solution designed for everyday clinical use by healthcare providers who care for persons with HIV/AIDS. AVIGA™ allows the clinician to treat patients based on established practice workflow, while all the Ryan White information is being captured and catalogued in the background. In addition, the completeness of RSR-required data can be reviewed on a patient-by-patient basis, and sites have the option to edit or revise information before and after the RSR is generated.
What if a clinical practice already has an EHR solution, but it lacks Ryan White CARE Act reporting functionality? AVIGA REPORTER™ is a web-based data-reporting module that can be interfaced with existing EHR solutions to assimilate the information and requirements unique to HIV/AIDS management, including Ryan White CARE Act reporting features. As an add-on module, AVIGA REPORTER™ is able to capture all relevant RSR data that resides in an existing EHR as well as identify gaps in data required for the RSR.
All fields necessary for Ryan White CARE Act reporting are highlighted by icons throughout AVIGA™ and AVIGA REPORTER™. In addition, the Ryan White Reporting section in AVIGA™ allows clinicians to view all RSR-required data in one screen during a patient visit. Further, the Ryan White reporting functionality includes the ability to auto-populate RSR-required data and allow clinicians the option to periodically review the completeness of collected RSR for each patient.
One of the major challenges of installing an EHR system is the time and expense involved in infrastructure set-up and IT support for locally hosted systems. However, EHR solutions that follow a SaaS web-based model offer a number of benefits, including:
Two of the major requirements for SaaS-based EHR solutions are ensuring data security and protecting patient privacy. SaaS platforms should offer secure web hosting, redundant systems and access, and all physical and electronic security (eg, firewalls, anti-virus protection, spam filters, block intruders) to protect patient data. For example, David Rebey, Head of US Business Operations at Janssen Diagnostics, Inc. noted that the AVIGA™ platform is designed to include measures for physical security, network security, and application security of a clinical practice’s data.
To read more about the benefits and challenges associated with platforms and HIT, please visit:
DISCLAIMER: THE INFORMATION CONTAINED IN THIS NEWSLETTER IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND REPRESENTS NO STATEMENT, PROMISE OR GUARANTEE BY JANSSEN DIAGNOSTICS, INC. CONCERNING RECEIPT OR PAYMENT OF GOVERNMENT INCENTIVES. JANSSEN DIAGNOSTICS, INC. STRONGLY URGES THAT YOU CONSULT WITH YOUR COUNSEL FOR ADVICE ON INCENTIVE ELIGIBILITY.
* vircoTYPE™ HIV–1 is a quantitative, biologically based, objective, data-driven system for predicting HIV-1 drug susceptibility from a viral genotype. In 2009, Janssen Diagnostics, Inc. (formerly Virco) acquired the HIV-disease-specific electronic medical records program LAB TRACKER™ HIV from Ground Zero Software.
On February 2nd, 2012, Virco Lab, Inc.
changed its legal name to Janssen Diagnostics, Inc.
Our website is in the process of being updated to
reflect these name changes.