Clinical Data Registries

Powers, Pyles, Sutter & Verville has developed the leading practice in representing clinical and public health data registries.

Our attorneys represent more than 25 national and state registries that collect data on clinical outcomes or public health outbreaks. We provide these registry clients with a unique blend of expertise on the corporate governance, contractual, privacy, and other health policy issues associated with the development and operation of clinical and public health data registries. Our clients include numerous nonprofit professional societies, public health associations, and other nonprofit and for-profit entities.

We assist our registry clients with the full spectrum of legal issues facing the formation and management of their data repositories. For instance, we prepare template participation agreements and HIPAA-compliant business associate agreements between registries and their data sources, and advise registry clients in negotiations of these agreements with particular data sources. We also prepare HIPAA policies and procedures for registries to cover their obligations as business associates of the covered entities that participate in the registries.

In addition, we draft and negotiate data sharing agreements for registries with industry, government, and others, data vendor/hosting agreements, and various funding agreements. We also advise our registry clients on other HIPAA and Common Rule compliance issues, including interactions with institutional review boards. Where necessary, we have provided assistance with corporate formation and governance issues, including preparing and filing articles of incorporation, drafting of bylaws, and preparing and submitting applications for tax-exempt status with the Internal Revenue Service.

Powers also assists our registry clients with their efforts to advocate for legislative and regulatory changes affecting data registries. We have helped organize, manage, and represent the Physician Clinical Registry Coalition, a group of nearly 25 medical society-sponsored or physician-led clinical data registries that advocate for public policies that will help promote and/or remove barriers to the development and operation of such registries. We have assisted the Coalition, as well as individual registry clients, in advocating on issues related to conflicts between HIPAA and the Common Rule, data blocking by electronic health record vendors, barriers to registry access to Medicare claims and federal death data, and protection of registry data from legal discovery.

PRACTICE AREAS
Healthcare