In April, as required by the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA), the Cybersecurity and Infrastructure Security Agency (CISA) issued a Notice of Proposed Rulemaking (NPRM) introducing new requirements for critical infrastructure entities to report certain cybersecurity incidents. CISA sought comment from the public, and several healthcare stakeholders have provided feedback on the proposed rule.

Background

The proposed rule requires critical infrastructure entities to report cybersecurity incidents to CISA within 72 hours of detecting a cybersecurity incident and within 24 hours of making a ransomware payment. The types of covered incidents include:

• Unauthorized system access
• Denial of Service (DOS) attacks with a duration of more than 12 hours
• Malicious code on systems, including variants if known
• Targeted and repeated scans against services on systems
• Repeated attempts to gain unauthorized access to systems
• Email or mobile messages associated with phishing attempts or successes
• Ransomware attacks against critical infrastructure, including the variant and ransom details if known

The types of information that must be submitted to CISA include:

• Incident date and time
• Incident location
• Type of observed activity
• Detailed narrative of the event
• Number of people or systems affected
• Company/Organization name
• Point of Contact details
• Severity of event
• Critical infrastructure sector
• Anyone else who has been informed

CISA will share the information with federal and non-federal partners to improve detection and the minimization of the harmful impacts on critical infrastructure entities, accelerate mitigation of exploited vulnerabilities, and allow software developers and vendors to develop more secure products. The information will also be shared with law enforcement to help with the investigation, identification, capture, and prosecution of the perpetrators of cybercrime.

Healthcare Industry Groups Give Feedback to CISA

The Workgroup for Electronic Data Interchange (WEDI) and the Medical Group Management Association (MGMA) have called for CISA to align the reporting time frame with the HHS’ Office for Civil Rights, as having to submit reports to multiple agencies will place a considerable administrative burden on healthcare organizations. MGMA believes the new reporting requirements will be overly burdensome for medical groups, and the duplicative reporting requirements may affect the ability of those groups to operate effectively, especially when dealing with a cyberattack.

MGMA explained that under HIPAA, covered entities must report cybersecurity incidents to the HHS’ Office for Civil Rights within 60 days for HIPAA compliance. Rather than layering different reporting requirements on each other, MGMA suggests that CISA should work closely with the HHS to seamlessly incorporate data that must reported under HIPAA. This will promote collaboration and prevent covered entities from reporting the same incident multiple times in different formats. MGMA said the sized-based criteria for reporting means small medical groups will not have the burden of reporting incidents but using the SBA definition means that many small physician offices will be impacted, even practices with annual revenues as low as $9 million.

The short timeframe for reporting incidents was criticized by WEDI, which said it could take longer than 72 hours to gather all the necessary information for the initial report. WEDI has called for CISA to be flexible with the reporting timeframe, such as allowing the initial report to be submitted with as much information as it has been possible to gather within 72 hours and allowing additional information to be submitted after that deadline as it becomes available. WEDI also proposes a carve-out for certain ransomware attacks. WEDI has requested that CISA not consider an attack to be a data breach if no protected health information has been accessed, provided the entity has made a good faith effort to deploy a recognized security program and has implemented security policies and procedures.

CHIME/AEHIS Members Express Concern

The College of Healthcare Information Management Executives (CHIME) and the Association for Executives in Healthcare Information Security (AEHIS) have urged CISA to consider that the core mission of healthcare is patient safety and not to implement regulatory requirements that could jeopardize that mission.

One concern from their members is the reporting requirements under HIPAA, which require security breaches to be reported to OCR within 60 days of the discovery of a data breach. They are concerned that the clock would start ticking for reporting under HIPAA on the date of submission of the incident report to CISA, and that could create considerable additional burdens for HIPAA-regulated entities. CHIME and AEHIS have asked CISA to clarify the reporting requirements for managed service providers and other third-party service providers that provide products or services to HIPAA-covered entities, requesting that the service provider be considered the covered entity for reporting under CIRCIA.

After the initial incident report, critical infrastructure entities are required to submit supplemental reports following a significant cybersecurity incident, with those supplemental reports submitted without delay or as soon as possible. There is concern that with the threat of enforcement, HIPAA-covered entities may feel compelled to prioritize reporting of incidents over patient safety. CHIME/AEHIS have requested that the supplemental reports be submitted every 72 hours at a minimum or every 5 days, and for those reports to only be required if substantial new or different information becomes available.

CHIME/AEHIS point out that the definition of larger hospitals – those with 100 or more beds – is inadequate and that a more nuanced approach is required with other factors considered other than bed count, and not require reporting of incidents by critical access hospitals (CAHs), which are already under considerable financial strain. Making CAHs report incidents could increase the financial strain on the hospitals, leading to more closures and reduced access to healthcare for patients.

CHIME/AEHIS have received feedback from their members about the level of detail required by CISA about the security architecture of breached entities. “If CISA requires hospitals and healthcare systems to define their entire security architecture, that is a tremendous amount of information to include in a report,” explained the industry groups. “Our members do not believe that CISA needs to know an entire description of an organization’s security program – as it is not helpful to fulfill the purpose of CIRCIA, is potentially considered intellectual property (IP), and/or sensitive for the organization.”

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On April 22, 2024, the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) released Version 2.0 of the Trusted Exchange Framework and Common Agreement (TEFCA).

TEFCA establishes the technical infrastructure model and governing approach for different health information networks and their users and allows them to share clinical information with each other. The ONC requires health information networks that participate in TEFCA to begin implementing the new version and support the Health Level Seven Fast Healthcare Interoperability Resources standard. ONC has also published Participant and Subparticipant Terms of Participation, which details the requirements for Participants and Subparticipants, compliance with which is required for participation in TEFCA. Version 2.0 of the Common Agreement will make it easier for participating health information networks to share data with each other and will also make it easier for patients to access their health data through digital health apps.

“We have long intended for TEFCA to have the capacity to enable FHIR API exchange. This is in direct response to the health IT industry’s move toward standardized APIs with modern privacy and security safeguards, and allows TEFCA to keep pace with the advanced, secure data services approaches used by the tech industry,” said Micky Tripathi, Ph.D., national coordinator for health information technology. “I want to commend the effort put forth by the TEFCA and FHIR communities to help get us there with the release of CA v2.0.”

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New York Attorney General, Letitia James, has announced a settlement with New York’s largest health network, Northwell Health, to resolve allegations it deceptively advertised its emergency departments as COVID-19 testing sites during the COVID-19 public health emergency. Northwell Health claimed in advertisements that three emergency departments in New York City and Long Island were COVID-19 testing sites; however, when patients visited to be tested they were billed for emergency room visits.

The Office of the Attorney General (OAG) investigated Northwell Health after complaints were received from patients who claimed they had been overcharged for testing. OAG investigated and found that Lenox Hill Hospital, Lenox Health Greenwich, and Huntington Hospital had signs advertising their emergency departments as COVID-19 testing sites between March 2020 and March 2021. Hundreds of patients visited the emergency departments solely to be tested for COVID-19 but were billed standard emergency department charges. In the case of Huntington Hospital, even patients who used the drive-in testing facility were charged for emergency room visits. OAG determined that Northwell Health collected $81,761.46 in out-of-pocket payments from 559 New Yorkers for COVID-19 tests and related services, and patients visiting the emergency department for other reasons were also charged for COVID-19 tests.

OAG found that the actions of Northwell Health violated New York Executive Law § 63(12) and General Business Law §§ 349 and 350. Under the terms of the settlement, Northwell Health has issued more than $400,000 in refunds to 2,048 patients and will pay a civil monetary penalty of $650,000 to the state. “During a time of great stress at the height of the pandemic, Northwell Health caused more worry and frustration for New Yorkers who were sent emergency room bills for simply taking a COVID-19 test,” said Attorney General James. “Today we are putting money back in New Yorkers’ pockets after Northwell Health misled them. New York patients should not get surprise fees, and I encourage anyone who thinks they’ve been taken advantage of through deceptive advertising to file a complaint with my office.”

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The HHS Office of the National Coordinator for Health Information Technology (ONC) has provided an update to Congress on the progress that has been made on the access, exchange, and use of electronic health information through trusted health information networks (HINs) and health information exchanges (HIEs).

HealthIT is integral to healthcare delivery, and it has become even more so since the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Across the United States, hundreds of physician offices, hospitals, and health systems now use ONC-certified healthIT to access, process, store, and exchange electronic health information (EHI) and ONC reports significant progress in the past year toward nationwide interoperability, and connecting nationwide, trusted HINs.

According to the ONC report, 85% of hospitals have electronically queried or found patient health information through various methods; 64% of hospitals reported using nationwide networks that enable data exchange across different healthIT systems in 2021, around half of physicians searched for or queried patient health information via their EHR when seeing a new patient in 2021, and HINs are one of the most common methods used by hospitals to electronically send and receive summary of care cards.

There are, however, barriers to progress. As explained to Congress in a February 2023 report, those barriers have resulted in uneven progress across healthcare and have affected the ability to realize the full potential of certified health IT. In 2021, 72% of hospitals reported challenges exchanging data across different EHR vendor platforms, 54% faced challenges developing customized interfaces, 57% faced challenges matching and identifying the correct patient between systems, and in 2022, around three-quarters of hospitals experienced at least one challenge to electronic public health reporting.

HIN’s and NIEs each have limitations, which are being addressed through the Trusted Exchange Framework and Common Agreement (TEFCA). TEFCA simplifies network participation by providing a way for healthcare providers, health plans, and patients to make a single connection to access EHI on a nationwide scale, and TEFCA supports a broader range of exchange purposes, including treatment, payment, healthcare operations, public health, government benefits determination, and individual access services.

ONC published version 1.1. of TEFCA in November 2023, and in December, five organizations completed the TEFCA onboarding process and were officially designated as Qualified Health Information Networks (QHINs), and a further two organizations were designated as QHINs in February 2024.

ONC anticipates more organizations will be designated as QHINs in the coming year and reports that most hospitals are aware of TEFCA and plan to participate. ONC expects TEFCA will scale significantly and will create a pathway for modern information sharing and patients will experience the benefits, especially those that have multiple healthcare providers as it will make it much easier to efficiently access and manage their own health information, although virtually everyone that uses the healthcare system will benefit from connected HINs eventually, said ONC.

ONC thanked Congress for its commitment to the 21st Century Cures Act, which envisioned TEFCA, and recommended support for the implementation of the health IT provisions of the Cures Act.

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The Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) has proposed a rule that implements cyberattack and ransom payment reporting requirements for critical infrastructure entities, as required by the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA).

In March 2022, CIRCIA was signed into law by President Biden, one of the requirements of which was for CISA to develop and implement new regulations that require critical infrastructure entities, including hospitals and health systems, to report covered cyber incidents and ransomware payments to CISA. The purpose of the reporting is to provide CISA with timely information about cyberattacks to allow resources to be rapidly deployed and assistance provided to support victims of cyberattacks and allow CISA to rapidly identify cyberattack trends and disseminate information to help network defenders prevent further attacks.

When developing the new requirements, CISA consulted with various entities, including the Sector Risk Management Agencies, the Department of Justice, other appropriate Federal agencies, the DHS-chaired Cyber Incident Reporting Council, and non-federal stakeholders.

Incidents That Should Be Reported

• Unauthorized access to systems
• Denial of Service (DOS) attacks that last more than 12 hours
• Malicious code on systems, including variants if known
• Targeted and repeated scans against services on systems
• Repeated attempts to gain unauthorized access to systems
• Email or mobile messages associated with phishing attempts or successes
• Ransomware against critical infrastructure, including variant and ransom details if known

Information That Should be Shared

1. Incident date and time
2. Incident location
3. Type of observed activity
4. Detailed narrative of the event
5. Number of people or systems affected
6. Company/Organization name
7. Point of Contact details
8. Severity of event
9. Critical Infrastructure Sector if known
10. Anyone else that has been informed

Proposed Timeframe for Reporting

Time is of the essence when reporting incidents. The sooner CISA is informed, the faster information can be shared to warn other organizations in the sector about attackers’ tactics, techniques, and procedures. Covered entities will be required to report covered incidents within 72 hours, and ransom payments will need to be reported within 24 hours of payment being made.

Since some of the requirements of CIRCIA are regulatory, CISA is first required to publish a Notice of Proposed Rulemaking (NPRM) in the Federal Register and accept public comments for 60 days. The NMPR was published in the Federal Register on March 27, 2024. The Final Rule will be published within 18 months of the date of the NPRM.

The new reporting requirements will not be mandatory until the Final Rule takes effect; however, CISA encourages all critical infrastructure entities to voluntarily report cyberattacks and ransom payments ahead of the compliance date. The information shared will allow CISA to provide assistance and warnings to other organizations to prevent them from suffering similar attacks.

A fact sheet has been released that summarizes key requirements and the NPRM can be viewed in the Federal Register.

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Florida Governor Ron De Santis has signed the “Live Healthy” legislative package into law, which enhances current policies and includes $716 million in health care investments. The purpose of the legislative package is to strengthen Florida’s health care workforce, broaden access to quality health care, and foster innovation in the industry. The new laws introduce new compliance requirements for hospitals with emergency departments.

The bills signed by Governor DeSantis on March 21, 2024, are:

• SB 7016, which creates and expands training programs that will help to develop and retain Florida’s health care workforce.
• SB 7018, which harnesses the innovation and creativity of entrepreneurs and industry leaders to meet the needs and challenges of Florida’s evolving health care system.
• SB 1758, which formalizes some of the great work already underway within the Agency for Persons with Disabilities through the First Lady’s Hope Florida initiative.
• SB 330, which creates a new category of teaching hospitals dedicated to advancing behavioral health care through research, collaborating with our colleges and universities, and partnering with the state of Florida to address acute behavioral health care needs.
• SB 322, which creates public record and meeting exemptions for personal identifying information for practitioners participating in the Interstate Medical Licensure Compact, the Audiology and Speech-Language Pathology Interstate Compact, and the Physical Therapy Licensure Compact.

“We are taking action to bolster our health care workforce to keep pace with our state’s unprecedented growth,” said Governor DeSantis. “I applaud Senate President Passidomo for her dedication to this cause, which contributes to positioning Florida as the freest and healthiest state in the nation.”

New Compliance Requirements for Florida Hospitals with Emergency Departments

One of the bills, SB 7016, introduces new rules for hospitals with emergency departments (EDs), including hospitals with off-campus EDs. In Florida, many patients use EDs for non-emergent care or seek emergency care that could have been avoided if they received regular primary care. The bill requires hospitals with EDs to submit a diversion plan to the state that details how they will help these patients access the appropriate care setting if they present to the ED with a non-emergent condition or indicate that they do not have regular access to primary care.

The nonemergency care access plans (NCAPs), which must not conflict with the Emergency Medical Treatment and Labor Act, will require state approval by July 1, 2025, after which hospitals will be required to submit their plans annually and demonstrate that they are effective. If the NCAP does not receive state approval, it must be updated before a license is granted or renewed.

For Medicaid patients, the NCAP must include outreach to the patient’s Medicaid managed care plan, and at least one of the following:

1. A partnership agreement with at least one local federally qualified health center or another primary care setting. Staff at the ED must proactively seek to establish a relationship between the patient and the federally qualified health center or primary care setting if the patient indicates they do not have regular access to primary care.
2. The establishment and operation of a hospital-owned urgent care center within or in close proximity to the hospital ED, to which the patient can be diverted if, after an initial screening, the patient requires non-emergent healthcare services.

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U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is seeking feedback from stakeholders on ways to improve the regulation of clinical tests in the United States.

Since the Medical Device Amendments (MDA) of 1976 established the Food and Drug Administration’s (FDA) framework for medical devices more than 50 years ago there have been major advancements in in vitro diagnostic technologies that have required improvements to the framework. Similarly, advances in clinical laboratory medicine in the 35 years since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were enacted demand standards that reflect advances in molecular and genetic testing, as well as appropriate oversight of tests.

While Congress has considered proposals to reform these regulations, there have been no substantive updates to either of these frameworks. Sen. Cassidy is seeking feedback from stakeholders on potential updates to the FDA regulatory framework for diagnostics and the CLIA Regulatory Framework for LDTs, in particular, actions Congress should take to support innovation and ensure patient access to timely and advanced diagnostics.

Sen. Cassidy has asked 10 questions about each set of regulations, such as how well they are currently working, whether updates are needed, areas in need of improvement, and the regulatory burden of any updates to the regulations. The request for information can be found here and responses should be provided by April 3, 2024.

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