ABSTRACT
The Sponsor/initial Board or applicable governance entity should designate a Connected Communities of Care (CCC) Legal/Policy Track lead to work with CCC counsel to establish the framework and review all documents in each Track to ensure compliance. The Legal/Policy Track follows the requirements below to ensure a successful and legally compliant design, launch, implementation, and sustainability of a CCC. The Legal/Policy Track lead or other legal counsel for the CCC should examine the Sponsor or Funder requirements to determine any baseline parameters for the formal governance of the CCC. The CCC clinical Partners and Participants are likely to have many questions centered on consents and data sharing, necessary platform functionalities, and additional work related to the use of the CCC technology platform. The CCC legal and policy framework should avoid overly complex legal documents or significant revamping of workflows and existing policies and procedures unless absolutely necessary.
