Company: HCTI
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001213900-25-026218
Chunk: 175

Company: Healthcare Triangle, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 175
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8. The 21st Century Cures Act, which was passed and signed
into law in December 2016, includes numerous provisions intended to encourage this nationwide interoperability.

In February 2019, HHS’s Office of the National
Coordinator for Health Information Technology (“ONC”) released a proposed rule titled, “21st Century Cures Act: Interoperability,
Information Blocking, and the ONC Health IT Certification Program.” Following an extended public comment period, in March 2020 ONC
released the final rule which implements the key interoperability provisions included in the Cures Act. Specifically, it calls on developers
of certified EHRs and health IT products to adopt standardized application programming interfaces (“APIs”), which will help
allow individuals to securely and easily access structured and unstructured EHI formats using smartphones and other mobile devices. This
provision and others included in the rule create a lengthy list of new certification and maintenance of certification requirements that
developers of EHRs and other health IT products have to meet in order to maintain approved federal government certification status. Although
our current products do not require such certification, they may be required to be certified in future. Meeting and maintaining this certification
status will require additional development costs.

The ONC rule also implements the information blocking
provisions of the 21st Century Cures Act, including identifying reasonable and necessary activities that do not constitute information
blocking. Under the 21st Century Cures Act, the U.S. Department of Health and Human Services (“HHS”) has the regulatory authority
to investigate and assess civil monetary penalties of up to $1,000,000 against certified health IT developers found to be in violation
of “information blocking.” This new oversight and authority to investigate claims of information blocking creates significant
risks for us and our clients and could potentially create substantial new compliance costs.

Other regulatory provisions included in the ONC
Cures Act final rule could create compliance costs and/or regulatory risks for us. Because these regulations are subject to future changes
and/or significant enforcement discretion by federal agencies, the ultimate impact of these regulations is unknown.

25

There is significant uncertainty in the healthcare
industry, both as a result of recently enacted legislation and changing government regulation, which may have a material adverse impact
on the businesses of our hospital clients and ultimately on our business, financial condition, and results of operations.

The healthcare industry is subject to changing
political, economic, and regulatory influences that may affect the procurement processes and operation of healthcare