The Educational Series on Data and Financial Transparency has been updated and is now available in the Member Center section of ISMPP’s website. The Educational Series is provided as a benefit to ISMPP members.
An important addition to the Educational Series slide set is new information about the expansion of “covered recipients” in the US Physician Payment Sunshine Act (ie, Sunshine Act). The SUPPORT for Patients and Communities Act (H.R.6), established in 2018, expanded the definition of “covered recipients” under the Open Payments program to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. This new requirement applies to all data submitted on or after January 1, 2022; companies must begin to collect reportable data beginning January 1, 2021.
Other key changes to the Educational Series slide set include:
- New – An interactive table of contents, along with improved organization of the slide deck, plus the addition of Key Takeaways for each main section
- An updated overview of the transparency requirements landscape
- New – Registration of Real-World Evidence (RWE) studies
- New – EU General Data Protection Regulation (GDPR) requirements
- New – US Food and Drug Administration (FDA) pilot program for protocol and clinical study report (CSR) publishing
- Update on available data sharing platforms, including Vivli
The Educational Series was developed by the ISMPP Global Transparency and Trends Committee and was “designed to educate members and provide them with real-world resources to inform their worldwide approaches to data and financial transparency.”
ISMPP extends a Special Thank You to the following members of the Global Transparency and Trends Committee who have contributed to updating the Educational Series slide set: Bhakti Kshatriya, Karen Mittleman, Allison Galway, and Emily Bruce.