Shannon West, Chief Product Officer for Datavant
The healthcare industry is facing immense pressure to provide patients with seamless and compliant access to their medical records. Despite recent regulations that discourage information blocking and promote interoperability for secure access, the medical records retrieval process remains confusing and difficult. This affects both patients and healthcare providers, who need a comprehensive understanding of the patient’s record and context. Even in clinical trials, researchers are facing obstacles when trying to access patient medical records in a timely and compliant manner. This challenge begins with provider organizations and affects not only patient care but academic and clinical research, where patient data is crucial for advancing knowledge. Access barriers to data hinder progress and discovery in the medical field.
Enabling secure and quick access to patient information is crucial for the healthcare industry to advance research goals and pave the way for significant progress. Although traditional record retrieval processes pose challenges, having a vision that prioritizes secure and compliant access to complete patient records through a consistent and protected connectivity platform is essential for developing life-changing treatments for patients across different diagnoses and research domains.
Researchers Need the Data
The demand for patient data has never been greater in clinical research. The pandemic has driven patient interest in clinical trial participation, while pharmaceutical companies are intensifying efforts to develop and deliver effective medications across diagnoses. Further, increased awareness of health equity in care provision has piqued the interest of researchers who want to proactively address health disparities through research. The need for data can no longer be fulfilled by traditional, localized methods. Data needs to come from the breadth of health systems that serve our population nationally and eventually globally.
However, hospitals have varying processes and protocols for accessing medical records, which involve different mechanisms for submitting requests and indicating the information required. These procedures are not always straightforward, and they hardly ever scale. Furthermore, there are different policies at the federal, state, and local levels governing the release of medical records, making matters even more complex. Patients who are chronically ill and receive care from various providers and health systems are typically the ones who must wade through the complexity of contributing to a registry or seeking past records to confirm clinical trial eligibility. The portals they use to connect with may be challenging to access, or they may not provide the necessary depth of data for the specific use case. Retrieving patient records can be tedious and frustrating, involving file downloads and uploads, resulting in delays and affecting participation.
While health information exchanges (HIEs) and health information networks (HINs) can enable access to patient data for point-of-care decision-making for treatment purposes, these are off limits—and, further, incomplete—for clinical trials, clinical research, or building registries. For example, in building an oncology registry, researchers require specific tumor histology and treatment decisions made via detailed clinician notes to understand cancer staging through pathology reports. This information is not commonly found via HINs or HIEs. The patient’s entire longitudinal journey is vital in elucidating exactly how the patient has interacted with the care system at various stages of the healthcare journey.
Record Retrieval is Burdensome
Most commonly, research teams contact patients’ health systems—with an average of three per patient—one by one to retrieve medical records. To say this is a huge administrative undertaking would be an understatement. Participation may suffer as a result of retrieval difficulties, and incomplete data can also compromise eligibility.
Steps in the process may include:
- Securing written authorization from each patient in a format that meets the requirements of each healthcare institution.
- Identifying which healthcare facilities have the patient’s medical records, often requiring the patient to list all their physicians.
- Locating the appropriate department and contact information for each health system.
- Submitting the medical record request, often through fax.
- Ensuring that the correct authorization form is used, as mistakes are common and may result in further delays.
- Navigating the health information management department’s payment procedures to provide payment for the record.
- Keeping track of which institutions have provided the requested records and following up multiple times with those that have not.
- Dealing with the challenge of parsing faxed records, which can be difficult to read.
- Starting the process over again and submitting new requests manually when follow-ups are required.
These retrieval processes for patient records, which often lack completeness for the use case, can span months or even years, leaving much room for improvement.
Implement Changes to Make Record Access Easy
The need for democratizing access to patient data for research is critical. However, the current system of obtaining medical records from different healthcare providers, EHRs, HIEs, and HINs is highly fragmented and inefficient. To solve this issue, a single-entry point to a network of channels that can deliver the required data to the right authorized requester in a streamlined and secure manner is essential. Such an approach will allow requesters to access a large pool of real-world data seamlessly and securely, providing a robust foundation for clinical research.
To achieve this goal, a network of over 2,200 hospitals and 19,000 clinics (40% of all providers in the U.S.) and hundreds of digital connections, including direct APIs, to EHRs, HIEs, HINs, and the largest health systems, is needed. Researchers must be able to retrieve medical records from a single entry point that routes their requests to appropriate channels in a seamless, secure, and efficient manner.
With a strong, stable, and secure records retrieval process, clinical research will have the potential to improve clinical discovery, academic pursuits, and patient care. Researchers can maximize their yields while minimizing friction and turnaround time, resulting in more meaningful clinical data and better outcomes for patients.
About Shannon West
Shannon West is the Chief Product Officer for Datavant. In this position, West leads digital interoperability efforts and helps to further the company’s growth with innovative new technologies, solutions and business models. She is focused on accelerating the company’s pace of innovation in making the Datavant vision possible, to power every health decision with the right data at the right time in the right format.