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.”

The post ONC Releases Common Agreement Version 2.0 appeared first on HIPAA Journal.

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.”

The post NY Attorney General Finds Northwell Health Deceptively Advertised COVID-19 Testing Sites appeared first on HIPAA Journal.

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.

The post ONC Reports on Progress on Advancing Nationwide, Trusted Health Information Networks appeared first on HIPAA Journal.

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.

The post CISA Proposes Cyberattack Reporting Rules for Critical Infrastructure Entities appeared first on HIPAA Journal.

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.

The post New Compliance Requirements for Florida Hospitals with Emergency Departments appeared first on HIPAA Journal.

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.

The post Sen. Cassidy Seeks Feedback on the Regulation of Clinical Tests appeared first on HIPAA Journal.

Companies in Florida may soon be immune from lawsuits if they suffer data breaches provided that prior to the cybersecurity incident, they have been maintaining a cybersecurity program that substantially aligns with industry standards, cybersecurity frameworks such as the NIST CSF, or a state or federal law such as HIPAA, and they comply with Florida’s data breach notification law. The cybersecurity incident liability bill – House Bill 473 – was recently passed by the Florida legislature and now heads to the state governor’s desk for his signature. Governor Ron DeSantis is expected to sign the bill into law.

Currently, healthcare organizations in the state of Florida have a degree of immunity from regulatory sanctions and penalties if they can demonstrate that they have implemented recognized security practices that have been continuously in place for the 12 months prior to a data breach, following a 2021 amendment to the HITECH Act. When determining appropriate penalties in its enforcement activities, the HHS’ Office for Civil Rights will consider the recognized security practices that have been in place and will reduce the penalties accordingly. There are no provisions in HITECH or HIPAA that provide immunity from or limit liability in class action data breach lawsuits.

Any significant healthcare data breach is likely to see one – or most likely several – class action data breach lawsuits filed for exposing sensitive data, and the cost of defending against those lawsuits and paying settlements is considerable. If lawsuits are likely to be filed following any data breach regardless of the cybersecurity measures that have been implemented, then businesses may simply accept the risk and fail to invest appropriately in cybersecurity.

The aim of the bill is to incentivize organizations to invest in security and implement cybersecurity measures to protect the personal data they collect and store as it is in their best interests to do so. The bill goes a step further than similar laws that have been enacted in Ohio, Utah, and Connecticut, where companies that implement appropriate security measures have limited protection against class action data breach lawsuits. In Florida, companies will be provided with immunity from more types of claims and there are no carve-outs for failing to address known threats, and immunity is not conditioned on compliance with a cybersecurity program. Should the bill be signed into law it will be effective immediately.

While the law will undoubtedly be good for businesses, the benefits to consumers are questionable. If the law does have the intended effect and companies invest in cybersecurity as a result, Florida residents will be less likely to have their data compromised. However, in the event of a data breach, consumers will have to cover the cost of protecting themselves against identity theft and fraud and will incur out-of-pocket expenses, as well as costs if they do fall victim to identity theft and fraud if they cannot recover those costs by other means.

The post Florida Legislature Passes Bill Providing Companies with Immunity from Data Breach Lawsuits appeared first on HIPAA Journal.