Compliance

Our Approach to Compliance

Bionara is built for pharmaceutical and life sciences teams that operate under strict medical, legal, and regulatory (MLR) requirements. Compliance is not an afterthought — it is embedded into how the platform works, from HCP data handling to outreach workflows.

HCP Data & the Sunshine Act

All healthcare professional (HCP) data surfaced by Bionara is sourced from publicly available government registries and databases, including the NPI Registry, Open Payments (CMS), PubMed, ClinicalTrials.gov, and NIH Reporter. We do not collect or store protected health information (PHI).

Open Payments data is presented in accordance with the Physician Payments Sunshine Act, providing transparency into industry–HCP financial relationships while respecting the public nature of the data.

Outreach Compliance

Bionara's AI-enabled outreach tools are designed with pharmaceutical communication regulations in mind:

• All outreach content is generated as drafts that can be reviewed, edited, and approved before sending — ensuring MLR review processes are respected
• Outreach templates and messaging adhere to non-promotional communication guidelines for Medical Affairs and MSL teams
• The platform maintains a complete audit trail of all outreach activity, including who sent what, when, and to whom
• Teams can configure outreach rules and approval workflows to match their organization's internal compliance policies

Anti-Kickback & Fair Market Value

Bionara does not facilitate payments, transfers of value, or compensation to HCPs. The platform is an intelligence and workflow tool — it helps teams identify, understand, and communicate with HCPs, but does not manage financial transactions. Organizations using Bionara remain responsible for ensuring their engagement activities comply with the Anti-Kickback Statute and fair market value requirements.

Off-Label Communication Safeguards

Bionara's outreach tools are designed for non-promotional, scientific exchange consistent with Medical Affairs best practices. The platform does not generate promotional content and is not intended for use by commercial sales teams in direct promotional activities. AI-generated drafts are grounded in published literature and clinical data to support compliant scientific discussion.

CAN-SPAM & Electronic Communication

All electronic outreach facilitated through Bionara complies with the CAN-SPAM Act and applicable electronic communication laws. This includes clear sender identification, accurate subject lines, and opt-out mechanisms for recipients. Organizations are responsible for maintaining their own opt-out lists and suppression files.

Audit Trail & Recordkeeping

Bionara maintains detailed logs of platform activity to support your organization's compliance recordkeeping requirements. This includes HCP search history, outreach activity, engagement records, and user actions — all exportable for internal audits or regulatory inquiries.

Shared Responsibility

Bionara provides the tools and safeguards to support compliant HCP engagement, but compliance is a shared responsibility. Your organization is responsible for ensuring that all interactions with HCPs conducted through the platform comply with your internal policies, applicable laws, and industry codes of conduct (including PhRMA Code, EFPIA Code, and local regulations).

Questions

For compliance-related questions or to discuss how Bionara fits into your organization's regulatory framework, contact us at hello@bionara.com.