Company: TEM
Filing Date: 2025-02-24
Form Type: 10-K
Source: 0000950170-25-025603
Chunk: 114

Company: Tempus AI, Inc.
Filing Date: 2025-02-24
Form: 10-K
Item: Item 1
Chunk 114
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, documentation of tests ordered, billing practices and claims payment and/or regulatory agencies enforcing those laws and regulations; 

•federal and state health care fraud and abuse laws; 

•federal and state laboratory anti-mark-up laws; 

•coverage and reimbursement levels by Medicare, Medicaid, other governmental payers and private insurers; 

•restrictions on coverage of and reimbursement for tests; 

•federal and state laws governing laboratory testing, including CLIA, and state licensing laws; 

•federal and state laws and enforcement policies governing the development, use and distribution of diagnostic medical devices, including laboratory developed tests, or LDTs; 

•federal and state laws and enforcement policies governing the use of AI in analyzing data, including data in healthcare related areas; 

•federal, state and local laws governing the handling and disposal of medical and hazardous waste; 

•federal and state Occupational Safety and Health Administration rules and regulations; 

•the Health Insurance Portability and Accountability Act of 1996, or HIPAA, and similar state data privacy and security laws; and 

•consumer protection laws; and 

•Similar foreign laws and regulations in the countries in which we operate or may operate in the future. 

In particular, the laws and regulations governing the marketing of diagnostic tests are complex, and there are often no sufficient regulatory or judicial interpretations of these laws and regulations. For example, some of our diagnostic tests are actively regulated by the FDA pursuant to the medical device provisions of the Federal Food, Drug and Cosmetic Act, or FDCA. The FDA defines a medical device to include any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including a component, part or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals. Many of our genomic and algorithmic diagnostic tests are likely to be considered by the FDA to be medical devices. Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, design, testing, manufacturing, safety, labeling, storage, record keeping, premarket clearance or approval, marketing and promotion and sales and distribution of medical devices in the United States to ensure that medical devices distributed domestically are safe and effective for their intended uses. In addition, the FDA regulates the import and export of medical devices. In the EEA, in order to place an in vitro diagnostic medical device, or I