California Comprehensive Compliance Program Statement

Last modified date:  December 08, 2021

This statement is being provided by Akili Interactive Labs, Inc. (Akili) pursuant to California Health and Safety Codes §§119400-119402 (Code) which requires pharmaceutical companies and certain medical device companies to make available their comprehensive compliance program and an annual written declaration of compliance with their compliance program.  

Akili is committed to conducting business in a manner which is built on trust and adherence to the highest ethical standards. Accordingly, we have built a compliance program that is based on the 2003 United States Department of Health and Human Services Office of Inspector General publication “Compliance Program Guidance for Pharmaceutical Manufacturers.” Our compliance program is also informed by the AdvaMed “Code of Ethics on Interactions with U.S. Health Care Professionals,” as our company manufactures and produces a prescription digital therapeutic that has certain characteristics similar to a medical device. The AdvaMed Code is similar to the PhRMA Code but is tailored to serve the needs and interactions that a medical device company may have with a healthcare professional. Our compliance program is tailored to our size, organizational structure, available resources, and the nature of our business.

Akili has set its annual dollar limit on gifts, promotional materials, or other items and activities that may be provided to a healthcare professional at $2,000. The dollar limit is a maximum only. This does not include fair market value payments that may be made for bona fide professional services including, but not limited to, serving on an advisory board, serving as a speaker, or performing other consulting services. This limit also does not include samples or free trials that may be provided or financial support for continuing medical education or other educational support.

Akili declares that, to the best of our knowledge, and based on our understanding of the Code, we are in compliance with our compliance program and the Code.  

A written declaration of compliance may be obtained by calling 857-254-3367. 

Overview of Akili’s Compliance Program

      I.         Written Policies and Procedures

Akili has written policies and procedures that are the backbone of its compliance program. All employees are required to read and understand the policies and procedures. The policies and procedures are periodically reviewed and updated to ensure they are in compliance with federal, state, and local laws, regulations, and guidance. Additionally, they are updated to reflect changes in the industry.  

     II.         Compliance Leadership

Akili’s compliance program is overseen by a Chief Compliance Officer. The Chief Compliance Officer has direct access to the CEO and Board of Directors. Akili also has a Compliance Committee that is comprised of members of senior leadership. Together, the Chief Compliance Officer and Compliance Committee oversee Akili’s compliance program. 

   III.         Training and Education

Akili conducts training and education on its compliance program for all employees. In addition to reading and acknowledging policies and procedures, employees periodically participate in live and web-based training. The compliance department also provides role-based training on an as needed basis.  

   IV.         Effective Lines of Communication

All employees are encouraged to raise concerns as they arise to either their manager, HR, compliance, or a member of senior management. Akili also maintains a third-party maintained hotline which allows employees to report anonymously.  

    V.         Monitoring and Auditing

Akili’s compliance program includes regular monitoring and auditing activities as needed and at the direction of the Chief Compliance Officer and the Compliance Committee.

   VI.         Disciplinary Guidelines

Akili has disciplinary guidelines that have been published for all employees to read and understand. The Company ensures all disciplinary action, as it occurs, is in alignment with these guidelines. 

 VII.         Corrective Action

Akili’s compliance program ensures that corrective action occurs whenever results of monitoring, auditing, or other observations dictate that it is needed. Corrective actions are appropriately documented and reviewed by the Chief Compliance Officer, and by the Compliance Committee as necessary.