Company: HCTI
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001213900-25-026218
Chunk: 38

Company: Healthcare Triangle, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 38
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 seizure, injunction,
and civil monetary policies—each of which could have an adverse effect on our business.

We may have to incur material expenses in order
to accommodate its client’s interoperability requests dictated by interoperability standards of exchange of health information.

Our clients are concerned with and often require
that our software solutions and health care devices be interoperable with other third-party health care information technology suppliers.
With the passing of the MACRA in 2015, the U.S. Congress declared it a national objective to achieve widespread exchange of health information
through interoperable certified EHR technology nationwide by December 31, 2018. 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