Company: HCTI
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001213900-25-026218
Chunk: 37

Company: Healthcare Triangle, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 37
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, and all private health plans and managed care plans, seeking payment for any services or products
that overbills or bills for items that have not been provided to the patient. We have in place policies and procedures that we believe
assure that all claims that are transmitted by our system and through our services are accurate and complete, provided that the information
given to us by our clients is also accurate and complete. If, however, we or our subcontractors do not follow those procedures and policies,
or they are not sufficient to prevent inaccurate claims from being submitted, we could be subject to liability.

24

In the event our software platforms and solutions
are found to be subject to FDA’s regulations and approval in connection with the certain types of medical devices our software integrates
with, we may have to incur additional costs or be subjected to potential criminal and civil penalties in case of the actual or perceived
failure of us to comply with such regulations.

Certain computer software products are regulated
as medical devices under the Federal Food, Drug and Cosmetic Act. The 21st Century Cures Act, passed in December 2016, clarified
the definition of a medical device to exclude health information technology such as Electronic Health Records; however, the legislation
did leave the opportunity for that designation to be revisited if determined to be necessary by changing industry and technological dynamics.
Accordingly, the Food and Drug Administration (the “FDA”) may become increasingly active in regulating computer software intended
for use in healthcare settings. Depending on the product, we could be required to notify the FDA and demonstrate substantial equivalence
to other products on the market before marketing such products or obtain FDA approval by demonstrating safety and effectiveness before
marketing a product. Depending on the intended use of a device, the FDA could require us to obtain extensive data from clinical studies
to demonstrate safety or effectiveness or substantial equivalence. If the FDA requires this data, we could be required to obtain approval
of an investigational device exemption before undertaking clinical trials. Clinical trials can take extended periods of time to complete.
We cannot provide assurances that the FDA would approve or clear a device after the completion of such trials. In addition, these products
would be subject to the Federal Food, Drug, and Cosmetic Act’s general controls. The FDA can impose extensive requirements governing
pre- and post-market conditions such as approval, labelling, and manufacturing, as well as governing product design controls and quality
assurance processes. Failure to comply with FDA requirements can result in criminal and civil fines and penalties, product