Research on rare genetic syndromes is often hampered by wide geographic location of patients, access and acceptance into qualifying trials, language, and monetary restrictions. The Expanded Access Program (EAP) has served as a bridge for these patients to gain access to much needed treatments available only in clinical trials. Authorizing an EAP in general can be difficult, but this is further compounded by the current pandemic. Campaigns to promote social distancing and shelter-in-place orders have complicated how EAPs are conducted. COVID-19 has also transformed and significantly impacted the regulation set in place for these programs. Remote settings have demanded ongoing reviews of HIPAA regulations in the current medical environment.
To assess the ability for patients to comply with HIPAA regulations, and continue to receive treatment through EAPs in a remote setting.
A literature review was conducted on several studies regarding barriers to enrollment, access, revisions made to HIPAA regulations, and compliance with these regulations, amid the COVID-19 pandemic. The focus was to better understand and work towards addressing barriers to patient’s healthcare needs.
Findings suggest that the needs of patients must be at the forefront of healthcare decisions, and regulations must be adapted among the ever-changing medical environment. Changes to HIPAA regulations and clinical trial and EAP access must continue to evolve to embrace the critical healthcare needs of patients and quality of life in remote setting.
With the changing medical environment, there is a need to re-evaluate healthcare delivery models and the regulations for protecting patients. Although HIPAA has relaxed certain requirements, due to the restrictions of the COVID-19 pandemic, the need for reform continues, as restrictions remain steadfast. Remote care is a relatively new and blossoming field within healthcare. Much work is needed to ensure continued safety and compliance. Re-evaluating and adapting HIPAA regulations will help ensure that patients with rare genetic syndromes not only have access to much needed investigational treatments and drugs, but that decisions and plans continue to hold ethical precepts; fairness, promoting good and minimizing risk of harm.
Tracey L. Harden, M.A. International Studies
Position: Director, Quality Assurance
Sania Masoud, MPH
Position: Quality Assurance Specialist
This poster was presented at the 2021 Academy of Managed Care Pharmacy Annual Meeting, held virtually, due to COVID-19. Click here for more information on this event. To download this poster, please complete the form below.