NY Hospitals Face Urgent Cybersecurity Regulations by October

October 2025 was the deadline. For New York’s general hospitals, the state didn’t just raise the bar, it re-wrote the rulebook. The new hospital cybersecurity regulations (codified at 10 NYCRR § 405.46) put prescriptive, repeatable, and measurable obligations on hospitals that go well beyond the federal HIPAA Security Rule. If your hospital hasn’t moved from “we should” to “we are” on these items, your risk profile, and your compliance footing is on thin ice.

The New Reality 

Starting with an incident-reporting requirement already in effect and with full compliance required by October 2, 2025, New York requires hospitals to implement a written, risk-based cybersecurity program that includes: designation of a Chief Information Security Officer (CISO), annual risk assessments, an incident response plan, annual penetration testing, multifactor authentication, lengthy audit-trail retention, and more. These aren’t optional “best practices”,  they’re regulatory obligations tied to licensing and potential civil enforcement. 

Why this matters - policy + pragmatics

Two things pushed this into law: 

1) Healthcare is being hit by more frequent and sophisticated cyberattacks (ransomware, data theft, supply-chain compromise)

2) Regulators want clear, auditable proof that hospitals are actively managing cyber risk and not just boxes checked in annual paperwork. New York’s rule explicitly expands the scope beyond just HIPAA-protected health information to include personally identifiable information and business data, forcing hospitals to map and govern a much wider data surface.

The state also recognized implementation costs and made funding available: the FY24 budget included a $500 million funding pool to help healthcare facilities upgrade technology and comply. That creates both a resource and a deadline pressure: hospitals that move quickly can apply for grants to offset modernization costs.

The hard requirements (what your board will actually ask about)

Here’s the checklist senior leaders will want evidence for everything must be written, reviewed, and attested to annually by a qualified CISO or designee:

• Designate a CISO (or qualified designee) who annually attests to policies and procedures. The CISO of each hospital shall report in writing, at least annually to the hospital’s governing body, on the hospital’s cybersecurity program and material cybersecurity risks.
  

• Annual risk assessments that meaningfully drive your security program. It must be carried out in accordance with written policies and procedures, and documented, including criteria for evaluating risks, threats, likelihood, impact, and how risks will be mitigated or accepted. Meaning the assessment isn’t just a formality but must feed into control choices and program design.
  

• Comprehensive written cybersecurity program covering identify/protect/detect/respond/recover. Hospitals are required to maintain a written cybersecurity program based on their risk assessment. The program must include detailed policies covering areas such as access control, vendor management, incident response, and business continuity.
  

• Annual penetration testing by qualified internal or external testers, plus vulnerability scanning and risk-based remediation. Vulnerabilities must be remediated promptly according to the level of risk they pose to hospital systems and data.
  

• Multifactor authentication (MFA) and identity/access governance, including periodic privilege reviews .Multi-factor authentication shall be utilised for any individual accessing the hospital’s internal networks from an external network, unless the hospital’s CISO has approved in writing the use of compensating controls.
  

• Incident response plan (roles, communications, remediation, continuity) and reporting within regulatory timeframes. The hospital or their designee shall notify the department as promptly as possible, but no later than 72 hours after determining a cybersecurity incident has occurred.
  

• Audit trails retained (the rule is prescriptive about recordkeeping expectations). Each hospital shall securely maintain systems that are designed to support normal operations and obligations of the hospital. Records pertaining to systems design, security, and maintenance supporting such normal operations shall be maintained for a minimum of six years.
  
  

Don’t do these two:

• Assuming HIPAA = done. New York is prescriptive and broader than HIPAA. HIPAA sets baseline privacy and security standards, but New York’s 10 NYCRR § 405.46 goes well beyond it with prescriptive technical, procedural, and reporting requirements. Hospitals must demonstrate proactive governance, risk-based testing, and formal CISO accountability, compliance cannot be inferred solely from HIPAA alignment.

• Delaying pentest procurement. Qualified testers are in high demand; schedule early. The regulation mandates annual penetration testing by qualified internal or external testers, but demand for certified assessors is high. Hospitals should plan and procure testing resources well in advance to ensure timely compliance and adequate follow-up remediation before the next reporting cycle.
  
  

Final word: This is an operational, financial, and reputational mandate

The New York rules are a warning shot: healthcare cybersecurity is now a regulated, auditable business function, and boards will be held accountable. The good news? With prioritized governance, rapid risk-based fixes, and the right testing cadence, hospitals can both reduce attack surface and show regulators the evidence they expect. Grants and state funding exist to help offset cost, but timing matters, those dollars are easiest to access when you have a clear, funded project plan.