Frequently Asked Questions
Haystack leverages machine learning tools to fully anonymize patient health records, automate their comprehension and annotation, and provide clinical researchers and healthcare providers with the tools and workflows they need to know when their patients become eligible for impactful trials. Haystack significantly reduces the time and labor required to enroll patients into clinical trials and provides users with a collaborative enrollment platform, enabling sponsors, CROs, and healthcare sites to coordinate more effectively.
More than 90% of study inclusion/exclusion criteria are found in the unstructured data of medical records. Unstructured data is often messy and abundant throughout EMRs, making manual eligibility evaluations difficult and time-consuming for research sites. Haystack's industry-leading AI/NLP extracts the most useful clinical information pertaining to a specific study from the unstructured data, which produces precise patient matches in unprecedented time.
Haystack tokenizes, or attaches a unique anonymized identifier, to each de-identified patient profile, which enables the research site to easily re-identify the patient for final screening and enrollment.
Haystack operates on a results-based pricing model, meaning customers are only charged for patients who are successfully randomized into a given study. The Haystack platform is completely free for healthcare sites to use, so it can be easily implemented across multiple studies and utilized for general patient care.
Haystack integrates into a healthcare site's electronic medical record (EMR) and processes (including HIPAA-compliant de-identification) all the unstructured data necessary for patient matching to a given study. The EMR integration and full implementation is conducted at no cost to healthcare sites, and the process typically takes 8-10 weeks in total for a new healthcare site. After implementation, healthcare sites gain access to all the benefits of being a member of the Haystack network, including increased access to new study opportunities and the ability to provide more novel care options to patients.
Haystack de-identifies all protected health information (PHI) in patient medical records to HIPAA-compliant standards prior to patient matching analysis. Within the Haystack platform, only authorized users at the healthcare site can re-identify patients and view PHI, which ensures this data is always protected and secure. In addition to HIPAA Expert Determination, Haystack is in the process of securing SOC2 and HITRUST certifications.
Implementation of the Haystack platform for studies typically does not require IRB approval, as no identifiable data is being used. However, in special cases, Haystack can provide any compliance materials required for IRB approval.