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Security Rules Update
By Practice Performance Partners (PPP)
In Part One, we covered changes to the Privacy Rules. Part Two will discuss the far more significant changes to the HIPAA Security Rules. As of this time, these rules are only proposed. We feel most of them will likely become law by late 2025 or early 2026. Due to the complexity and volume of changes, we are not recommending changes until the final rule passes. This summary will help explain the extensive changes being proposed.
The preamble to the amendment explains the severe impact cybersecurity issues are having on patient privacy.
• The Department of Health & Human Services (HHS) reports a 50% increase in data breach costs in the last four years.
• Victims of resultant identity theft incur, on average, costs over $13,000 to recover from the exposure.
• To date, only minor changes to the original Security Rule have been implemented and have resulted in little impact on the escalating number of protected health information (PHI) breaches.
• Healthcare entities are the hardest hit because the information collected is far more immutable than financial data. Addresses, phone numbers and even emails change, but social security numbers, driver's license numbers, date of birth and health care history rarely change.
• HHS also reports massive non-compliance with even the existing rules, stating small healthcare practices are “easy targets”.
It is based on this background that sweeping changes to the Security Rule are being proposed. HHS estimates the proposed changes will cost the healthcare sector $34 billion over the next five years. When asked during the comment period about the increased financial burden on providers to comply with the changes, the comment was “cost is not meant to free covered entities from their responsibility”.
The basic changes proposed are:
• Elimination of “addressable standards”. The scaling offered to small practices by allowing them to actively comply with less than half the security standards will be mostly eliminated. This will significantly increase the complexity and volume of data required for compliance.
• Mandatory encryption. While HHS has long stated encryption would be considered reasonable for all data, it will now be mandatory. This will mean encryption of all communications—email, text, FAX, server files, all backups and information on all testing equipment.
• Enhanced risk analysis. The risk analysis that was historically flexible based on individual practice characteristics will now become far more comprehensive and structured—regardless of practice size.
• Vulnerability scanning and testing, once recommended, will be required.
• More extensive regulations and documentation of incident response plans and active incidents will be required.
• Use of multi-factor authentication will be mandatory. It is not yet clear what levels of media devices this will apply to, but it appears the intent is to apply the rule to every login of every device that contains or can access PHI.
• Alignment with National Institute of Standards and Technology (NIST) guidelines. At this time, there is no definitive explanation of what “alignment” means. Full alignment with all NIST regulations would be next to impossible for small healthcare practices.
• Significant increase in penalties for non-compliance, negligence and repeat breaches.
WHAT DOES ALL THAT MEAN?
In a nutshell, it means that the process of risk analysis and management and changes in more than half the 45 security standards will be necessary. This will require a rewrite of every covered entity's Security Manual and customization to their practice.
Again, due to the significant forthcoming changes and potential edits to the rule, we do not recommend making any changes until the final rules are passed. There will likely be a time allowed to make these rather sweeping changes. PPP will be working with our colleagues to make these changes in the best way possible.
Questions on the new privacy rules can be directed to info@practiceperformancepartners.com.
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