What is Hospital Regulatory Compliance?
Hospital regulatory compliance means complying with the applicable standards of federal regulations such as HIPAA and OSHA, the conditions for participation in Medicare, and any state, local, or industry regulations that apply to a hospital’s activities. Because there are so many regulations for a hospital to comply with, it can be difficult to keep up with the volume of regulatory changes.
Depending on where a hospital is located and the nature of its activities, it may have to comply with more than a dozen sets of regulations and voluntary standards. Although there can be a high degree of crossover between the regulations, the speed at which standards are added, amended, or removed complicates hospital regulatory compliance. For example, as of January 2024, there were:
- Two Requests for Information, three Notices of Proposed Rulemaking, and one Proposed Rule advocating changes to HIPAA (not including Part 162).
- Five amendments to OSHA in the Pre-Rule stage, twelve amendments in the Proposed Rule stage, and seven amendments in the Final Rule stage.
- Twenty-four Proposed Rules and twenty Final Rules changing the conditions for participation in the Medicare and Medicaid programs.
- Dozens of FDA Rule changes – including some relating to blood donor eligibility, adverse drug experiences, and the regulation of biologics.
- Sixteen states with new privacy legislation at the committee stage or beyond – some of which will apply across state borders.
- Proposed changes to the NESHAP standard for hospital ethylene oxide sterilizers, a new Joint Commission certification program for hospitals, and the publication of the HPH Cybersecurity Performance Goals.
While not all the proposed changes will impact hospital regulatory compliance in every hospital, the volume of proposed changes listed above demonstrates how alert hospitals have to be to operational adjustments. Many regulatory agencies stipulate that ignorance of the Rules is no excuse for non-compliance, and most have the authority to impose significant penalties for non-compliance.
How to Achieve Hospital Regulatory Compliance
Achieving hospital regulatory compliance manually is difficult because implementing policies, procedures, and technologies to comply with the applicable standards of each regulation individually can result in conflicts with other regulations, while trying to approach hospital regulatory compliance holistically requires considerable resources – and a very large spreadsheet!
The solution to achieving hospital regulatory compliance is to use customizable healthcare compliance software which can accumulate relevant regulations, resolve conflicts (i.e., when a standard of one regulation preempts a standard of another regulations), and remove duplications (i.e., when a requirement of OSHA is the same as a condition of participation in Medicare).
The output can then be used by hospitals to conduct gap analyses, prioritize areas of non-compliance for remediation, and meet multiple compliance standards with one process. The software can also be used by hospitals to identify when policies need updating, when risk assessments and reviews of Business Associate Agreements are overdue, and when workforce refresher training is required.
Once a state of hospital regulatory compliance has been achieved, the software helps hospitals maintain the state of regulatory compliance by automatically updating its database whenever a change to a relevant regulation occurs or a new standard is added. In such cases, a new output is produced and hospitals are advised of any changes required to maintain regulatory compliance.
It is important to be aware that healthcare compliance software does not guarantee hospital regulatory compliance due to insider threats that can undermine compliance efforts. Nonetheless, the implementation of healthcare compliance software demonstrates a good faith effort to comply with applicable federal, state, and industry regulations and voluntary standards.
