FOLLOWING HIPAA REGULATIONS WHILE CONDUCTING EAPS IN A REMOTE SETTING

ABSTRACT

BACKGROUND: 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 complicated how EAPs are conducted. COVID-19 has also transformed and significantly impacted the regulations set in place for these programs. Remote settings have demanded ongoing reviews of HIPAA regulations in the current medical environment. OBJECTIVE: To assess the ability for patients to comply with HIPAA regulations, and continue to receive treatment through EAPs in a remote setting. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 shall 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.