Compliance & Conflict of Interest Disclosure

Nature of services

US Health Strategy Group, LLC ("USHSG") provides commercial strategy, market development, KOL infrastructure, and clinical adoption advisory services to healthcare companies and organizations. USHSG does not provide medical, clinical, legal, regulatory, financial, or investment advice. Advisory services are strategic and operational in nature.

Engagements are governed by a written Statement of Work or consulting agreement that defines scope, deliverables, timeline, and compensation. No advisory relationship exists absent a signed agreement.

Conflict of interest policy

USHSG maintains a policy of proactive conflict of interest identification and disclosure. Before accepting any engagement, USHSG evaluates whether existing or prior client relationships, financial interests, or personal relationships could impair objectivity or create an actual or apparent conflict.

If a potential conflict is identified:

• It is disclosed in writing to the prospective client before the engagement begins;
• USHSG and the client agree in writing on how the conflict will be managed or mitigated;
• If the conflict cannot be adequately managed, USHSG will decline the engagement.

USHSG does not simultaneously represent directly competing clients in the same product category or therapeutic area without the informed written consent of both parties.

Physician and expert advisor engagements

When independent physician advisors or clinical experts are engaged by USHSG on behalf of a client, the following standards apply:

• Compensation is set at fair market value (FMV), documented prior to engagement, and consistent with published FMV benchmarks for the relevant specialty and service type;
• All physician compensation is disclosed and documented in a written agreement;
• Engagements are structured to comply with the federal Anti-Kickback Statute, the Stark Law, the Physician Payments Sunshine Act (Open Payments), and applicable state equivalents;
• Physicians engaged as advisors are not compensated in connection with or contingent upon prescribing, purchasing, or recommending any product;
• USHSG does not facilitate honoraria or advisory arrangements designed to induce referrals or product utilization.

Clients are responsible for their own Sunshine Act reporting obligations. USHSG can provide documentation to support client reporting but is not the reporting entity under federal law.

KOL development and commercial strategy

USHSG's KOL development services are designed to support legitimate scientific exchange, clinical education, and advisory relationships. USHSG does not develop or manage speaker bureau arrangements intended to function as disguised promotional programs. All KOL engagement architectures developed by USHSG are reviewed against applicable OIG guidance and industry codes (AdvaMed, PhRMA).

Commercial strategy services do not include the preparation, review, or approval of promotional materials, clinical claims, or FDA-regulated communications. Clients are responsible for ensuring that commercial materials comply with applicable FDA promotional regulations and guidance.

No endorsement

USHSG does not endorse, recommend, or certify any specific medical device, drug, technology, or clinical protocol. Strategy advisory services are designed to inform commercial decisions, not to constitute clinical or regulatory recommendations.

Confidentiality

All client engagements are conducted under confidentiality obligations defined in the applicable consulting agreement or non-disclosure agreement. USHSG does not disclose client identity, engagement scope, or proprietary business information to third parties without written authorization, except as required by law.

Independence

USHSG's advisory recommendations are independent of any financial relationship with manufacturers, distributors, or technology vendors referenced in client strategy work. Where USHSG has or has had a compensated relationship with a third party referenced in client deliverables, that relationship is disclosed in writing.

Reporting a concern

To report a potential compliance concern, conflict of interest, or ethical concern related to USHSG's operations or engagements, contact:

US Health Strategy Group, LLC
Attn: Compliance
info@ushealthstrategygroup.com

All reports are reviewed by the principal. Retaliation against individuals who report concerns in good faith is prohibited.

Updates

These disclosures are reviewed annually and updated as needed. The effective date above reflects the most recent revision.