Health Technology Pilot Study
A Health Technology Pilot Study Agreement between an institution (e.g., a hospital, research center, or university) and a company providing the technology typically includes the following key components:
- Identification of both parties (institution and company)
- Background and objectives of the pilot study
- Description of the technology being tested
- Expected outcomes or goals of the pilot
- Specific use case(s) and environment(s) where the technology will be deployed
- Duration of the pilot study (start and end dates)
- Key milestones and deliverables
- Roles and responsibilities of each party
- Any training or support provided by the company
- Compliance with HIPAA (Health Insurance Portability and Accountability Act) or other relevant privacy laws (e.g., GDPR for European studies)
- Compliance with FDA regulations or other applicable regulatory bodies
- Institutional Review Board (IRB) approval, if applicable
- What data will be collected and how it will be used
- Ownership of raw and processed data
- Data security measures and storage locations
- Rights to analyze and publish findings
- Whether anonymized patient data can be shared with the company
- Ownership of improvements or modifications to the technology during the pilot
- Licensing terms for any newly developed intellectual property
- Patent rights, if applicable
- Protection of trade secrets and proprietary company information
- Safeguarding of institution-sensitive data
- Duration of confidentiality obligations beyond the study period
- Who is responsible for potential harm caused by the technology
- Liability waivers, if applicable
- Indemnification clauses to protect each party from claims arising from the pilot study
- Whether the company is providing the technology for free or at a discounted rate
- Cost-sharing agreements, if any
- Reimbursement terms for any expenses incurred
- Conditions under which the agreement can be terminated early
- Notice period for termination
- Responsibilities upon termination (e.g., data return, removal of equipment)
- Whether results of the pilot can be published in academic journals
- Requirements for company review prior to publication
- Any restrictions on press releases or marketing use of the results
- Choice of governing law (e.g., state law or international jurisdiction)
- Mechanisms for resolving disputes (e.g., mediation, arbitration)
