This guide emphasizes the importance of permissibility in launching new products, software, or services. While technical and commercial viability are critical, founders must ensure their ventures comply with the legal and regulatory frameworks of their target markets and regions of operation. Assessing permissibility early—before investing significant resources—is crucial, particularly in highly-regulated sectors such as healthcare, aerospace, defense, and food and beverage. Key permissibility considerations include:
Regulatory Compliance
Regulations are the rules, guidelines, and standards established by governmental or authoritative bodies to control and manage the operation, quality, safety, and compliance of products, services, and activities within specific industries. Regulations and their means of compliance can vary significantly across different sectors and regions, and often require obtaining approvals, certifications, or licenses to operate legally.
- Is the product subject to specific regulations or standards in your industry?
- Does the product require certification or approval from any regulatory bodies before it can be marketed or sold?
- For products involving data, how do data protection and privacy laws (e.g., GDPR, CCPA) apply?
- If planning for a global market, what international regulations need to be considered?
- How does the product fit within the current policy landscape, and are there any emerging policies that could affect it?
List of Regulatory Agencies
This list in not exhaustive, but should provide a good starting point for a thorough search
| Purview | AGENCY |
|---|---|
| Financial Services and Banking | U.S. Federal Reserve U.S. Securities and Exchange Commission (SEC) |
| Telecommunications | (Note that telecoms include anything that emits a signal, including micro antennae) Federal Communications Commission (FCC) |
| Energy and Utilities | U.S. Environmental Protection Agency (EPA) U.S. Department of Energy (DOE) |
| Aerospace | Federal Aviation Administration (FAA) |
| Defense | U.S. Department of Defense (DoD) |
| Pharmaceuticals and Biotechnology | Food and Drug Administration (FDA) |
| Automotive | National Highway Traffic Safety Administration (NHTSA) |
| Environmental Protection | U.S. Environmental Protection Agency (EPA) |
| Food and Beverage | Food and Drug Administration (FDA) U.S. Department of Agriculture (USDA) |
| Chemicals | Environmental Protection Agency (EPA) Occupational Safety and Health Administration (OSHA) |
| Privacy and Data Protection | Federal Trade Commission (FTC) For GDPR in the EU, information can be found through the European Data Protection Board (EDPB) |
Legal Considerations
Legal considerations encompass the body of laws and judicial decisions that define the rights, responsibilities, and constraints on individuals and organizations. This framework addresses issues such as intellectual property protection, contract enforcement, liability, corporate governance, and compliance with local, national, and international laws.
- What type of intellectual property protection is necessary, and how can it be secured?
- Are there potential conflicts with existing intellectual property that could affect the product’s market entry?
- What are the legal liabilities associated with the product, and how can they be mitigated?
- Considering the nature of the product or service, what legal structure is most suitable for the business?
More information on Intellectual Property at Tulane’s Office of Intellectual Property Management
Contractual Obligations and Market Constraints
Contract constraints significantly impact permissibility, as seen in scenarios where third-party innovations face barriers due to existing agreements. For example, inventing an improved nozzle for a leading remote surgery device might seem promising. However, regulatory requirements compel the device's manufacturer to ensure safety through validated attachments only, preventing the use of third-party parts. Hospitals using the device must contractually agree to use only the manufacturer's attachments, sidelining external innovations like the improved nozzle.
- Could existing exclusivity agreements in the market limit the adoption of the product?
- Are there standard contractual obligations or industry practices that could restrict the product’s implementation?
- What legal or contractual strategies can be developed to overcome these barriers?
Keep in mind that encountering challenges or negative findings during your concept’s permissibility review, though frustrating, is a normal part of the process. These hurdles can lead to adjustments in your technology and business strategy, ultimately enhancing your project's prospects for success.
