Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 327

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 327
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 developed, validated, performed, or marketed
and consequent risks to the public.

On May 6, 2024, the FDA
published the final rule on the regulation of LDTs (the “”). The New Rule followed more than a decade of efforts
both by the FDA to clarify the regulatory status of LDTs and Congress to reform the regulatory framework of in vitro diagnostics (IVDs),
including LDTs. The New Rule explicitly stated that IVDs offered as LDTs fall under the FDCA and the FDA would phase out its general enforcement
discretion approach for most LDTs. The New Rule would phase-out enforcement discretion over a period of four years and require compliance
with device registration and listing requirements, medical device reporting requirements, 510(k) clearance, denovo authorization
or Premarket Approval and the requirements of the FDA’s Quality System Regulation.

However, on March 31,
2025, the U.S. District Court for the Eastern District of Texas vacated the FDA’s final rule that aimed to regulate laboratory-developed
tests as medical devices under the Federal Food, Drug, and Cosmetic Act. The court ruled that the FDA lacked the statutory authority
to classify LDTs — diagnostic tests developed and used within a single laboratory — as medical devices,
emphasizing that LDTs are professional medical services, not tangible products subject to FDA regulation.

This decision halts the FDA’s
plan to phase out its general enforcement discretion over LDTs, which would have introduced new compliance obligations over a four-year
period. The court’s ruling underscores that oversight of LDTs falls under the CLIA, administered by the Centers for Medicare &
Medicaid Services (CMS), not the FDA. The FDA had until May 30, 2025, to appeal the decision, but decided against filing an
appeal in May 2025.

HIPAA and HITECH

Under the provisions of the
Health Insurance Portability and Accountability Act, or HIPAA, as amended by the Health Information Technology for Economic and Clinical
Health Act, or HITECH, the United States Department of Health and Human Services issued regulations that establish uniform standards
governing the conduct of certain electronic health care transactions and protecting the privacy and security of protected health information
(PHI) used or disclosed by health care providers and other covered entities. Three principal regulations with which DiamiR is required
to comply have been issued in final form under HIPAA: privacy regulations, security regulations, and