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The US healthcare industry is rigorously monitored against stringent regulatory norms. The industry needs to comply with a variety of standards including the Health Insurance Portability and Accountability Act (HIPAA), Centers for Medicare and Medicaid Services (CMS), American Society for Testing and Materials (ASTM), International Conference on Harmonization (ICH), International Electrotechnical Commission (ISO/IEC), and Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

These standards place considerable administrative and audit burden on the industry.

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