Next month, the New York State Department of Health (DOH) cybersecurity regulation for general hospitals comes into force, and all covered hospitals will be required to comply with all the new requirements. The cybersecurity regulation (10 NYCRR 405.46) took effect on October 2, 2024, and with immediate effect, general hospitals had to implement policies and procedures for reporting a material cybersecurity incident to the New York Department of Health’s Surge Operations Center (SOC) within 72 hours. Covered hospitals were given a year to implement compliance programs covering the other new requirements, and the deadline for compliance is now less than a month away. The compliance deadline is October 2, 2025.
Cybersecurity Requirements for General Hospitals
Hospitals in New York State already need to comply with the HIPAA Security Rule, but the cybersecurity regulation introduces many new requirements. Simply being HIPAA-compliant is no longer enough. Hospitals in the state, under HIPAA, are required to implement safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information; however, the cybersecurity regulation takes things further, as the requirements apply to electronic nonpublic information. The definition is broader than HIPAA, and applies to personally identifiable information (PII), which is information that could be used to identify a natural person, not just patients, as well as business-related records.
General hospitals are required to implement a cybersecurity program based on the hospital’s risk assessment. The cybersecurity regulation stipulates several required elements that go above and beyond those specified by HIPAA. The cybersecurity program must identify internal and external risks that may threaten the security or integrity of nonpublic information within the hospital’s systems and that may threaten the continuity of the hospital’s business and operations. Policies and procedures must be implemented to protect information systems and any nonpublic information stored within those systems from unauthorized access and other malicious acts. Defensive infrastructure is required, and systems must be in place for detecting and responding to cybersecurity events, which will allow the recovery of normal operations and services.
Policies and protocols must be implemented for limiting user access privileges to systems containing nonpublic information, and there must be regular reviews of access privileges. There is a new requirement for measures to mitigate the threat of email-based attacks, such as spoofing, phishing, and fraud, and regular reviews of email controls must be conducted to ensure they continue to be effective.
Security measures and controls include encryption of data at rest and in transit, and there are data minimization requirements. Policies and procedures are required for the secure disposal of nonpublic information that is no longer required. Multifactor authentication, risk-based authentication, or other compensating controls are required to protect against unauthorized access to nonpublic information.
In contrast to HIPAA, which requires regular risk analyses, hospitals are required to conduct an annual risk assessment to identify risks and vulnerabilities to nonpublic information, and the cybersecurity program must be assessed annually to ensure it remains effective. Testing is required, including annual penetration tests by a qualified internal or external party. Hospitals must have an incident response plan for dealing with cybersecurity incidents, and documentation demonstrating compliance must be maintained for six years.
Hospitals are required to appoint a Chief Information Security Officer (CISO), who must be a qualified senior or executive-level staff member with proper training, experience, and expertise, and the cybersecurity program must be managed by qualified cybersecurity personnel or a third-party service provider.
New Cybersecurity Requirements Likely to Be Rigorously Enforced
The HIPAA Journal has spoken with information governance strategist Matthew Bernstein, who has over 20 years’ experience helping organizations analyze risks, transform written policy into day-to-day practice, and make their data findable, compliant, and secure. Hospitals rely on his firm, Bernstein Data, to integrate retention schedules, discovery and classification, and defensible disposition into one operating model that meets HIPAA and state mandates while trimming storage costs and shrinking the ransomware “attack surface”.
Bernstein has warned that hospitals believing they are compliant with the new requirements because they are HIPAA compliant could be in for a shock, and any hospital waiting to implement the changes until the DOH starts enforcing the cybersecurity regulation could well end up paying a considerable financial penalty. The language of the regulation closely mirrors the NYS Department of Financial Services (DFS) requirements, and penalties for noncompliance can run from $1 million to $5 million.
“It’s clear that the NYS Dept of Health is taking a leaf from the NYS Department of Financial Services’ book, and that should be concerning to hospitals. The DFS has been an aggressive regulator about cybersecurity shortcomings of NYS companies, including healthcare providers with a “financial services” business, such as its recent $2 million settlement with Healthplex,” explained Bernstein. “There are significant commonalities between the new DOH regulation and the infamous 23 NYCRR 500 Cybersecurity Requirements for Financial Services Companies, and these requirements present new challenges for hospitals. It’s not just about a small set of defined PHI and making sure breaches are reported; there’s an expansive set of “personal” and “business-related” information to protect, and new risk assessment and mitigation operations to be adopted.”
With the compliance deadline fast approaching, hospitals need to ensure they have the policies, procedures, and protocols in place to comply with the new requirements. “New York hospitals don’t need to solve everything overnight, but they do need to demonstrate governance and intent,” Bernstein said. “Drafting a preliminary compliance roadmap with specific roles, accountability structures, and implementation priorities can go a long way in signaling good faith to regulators, board members, and insurers. Think of it as the scaffolding on which everything else will be built.”
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