ONCHHS Announces Last-Minute Changes to Compliance Deadlines

HHS Announces Last-Minute Changes to Compliance Deadlines

The US Department of Health and Human Services’ (“HHS”) Office of National Coordinator for Health IT (“ONC”) recently extended a few key compliance deadlines relevant to developers of certified health IT products, healthcare providers, and health information networks and exchanges (HIEs/HINs). Specifically, ONC pushed back certain requirements related to certification of certified health IT products and Information Blocking found in the ONC Cures Act Final Rule (ONC Rule), a rule that promotes seamless and secure access, exchange, and use of electronic health information through standardized health IT requirements. HHS stressed that it has extended these compliance deadlines to provide the healthcare industry additional time to implement the ONC Rule as the healthcare industry continues to grapple with the myriad challenges presented by COVID-19.

Developers of certified health IT are required to certify their products under the ONC Health IT Certification Program (“Program”). The Program now incorporates numerous new administrative and technical requirements outlined in the ONC Rule. The updated compliance deadlines give developers of certified health IT more time to update their currently certified products or build new products to comply with the new certification requirements, as well as more time to test those products. These developers also have additional time to attest under the Program that their products are compliant with specific conditions (known in the industry as the Conditions and Maintenance of Certification (“COC”)) that were updated by the ONC Rule.

Additionally, under the updated deadlines, developers of certified health IT, as well as healthcare providers and HIEs/HINs, have more time to comply with the new Information Blocking obligations required under the ONC Rule. Information Blocking is defined as any practice that is likely to “interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” There are eight narrow exceptions to these practices that allow an entity to engage in this type of behavior, most notably where the practice is intended to prevent harm, safeguard the security of electronic health information, or safeguard the privacy of the individual’s electronic health information.

The following is a summary of some key deadlines: 

Requirement Deadline 
Developers of certified health IT, healthcare providers, and HIEs/HINs cannot engage in Information Blocking. April 5, 2021 
Developers of certified health IT must attest that they comply with the CoC that were updated by the ONC Rule. May 1, 2022 
All products certified under the Program must align with the ONC Rule’s new technical certification requirements. December 31, 2022 (except with respect to a requirement related to electronic health information exports, which is not required until December 31, 2023) 
Developers of certified health IT must successfully test their certified health IT under real world conditions.Initial Plan for testing due December 14, 2021; Initial Results of testing due March 15, 2023 

For more information regarding the specific deadline updates, please see HHS’s official press release regarding the changes.

We anticipate that the updated compliance deadlines will be a welcome change given the many technical and compliance challenges presented by the ONC Rule. With this extra breathing room, now is the ideal time for companies to evaluate their compliance posture with respect to the ONC Rule and begin to develop strategies for adopting and implementing the new requirements under the ONC Rule, as implementation will require consultation with technical and legal teams. Beckage attorneys will continue to follow the evolving regulatory compliance guidance on deadlines and substantive requirements to assist clients in the health IT and healthcare industry as they navigate these and other new regulatory requirements. Beckage attorneys are uniquely experienced to help health organizations and tech companies of all sizes to navigate the complicated maze of legal and practical considerations raised by these and other health law regulations. Please do not hesitate to reach out if you are interested in discussing the ONC Rule’s potential impact on your business.

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RansomwareRansomware Activity Targeting the Healthcare and Public Health Sector

Ransomware Activity Targeting the Healthcare and Public Health Sector

Beckage is notifying organizations in the healthcare sector of a potential threat that may occur this weekend. We will continue to monitor this situation and provide updates as they occur.

Late last night the Federal Bureau of Investigations (FBI), Department of Health and Human Services (HHS), and the Cybersecurity and Infrastructure Security Agency (CISA) issued a warning about an imminent cybercrime threat to hospitals and healthcare providers. These organizations have credible information to suggest that there will be a widespread Ryuk ransomware attack this weekend. The threat is currently being investigated by the FBI, DHS and the NSA’s Cybersecurity Threat Operations Center.

What We Know

The cybercrime organization Ryuk is targeting the Healthcare and Public Health sector with Trickbot malware that may lead to ransomware attacks, data theft, and the disruption of healthcare services, a particularly concerning possibility considering the nation is still grappling with the COVID-19 pandemic.

Based on what we know about Ryuk, it is possible that the targeted healthcare entities have already implemented the encryption malware on healthcare organizations’ systems and the threat actors just have not commanded it to activate.  Given the threat, we urge all healthcare organizations to review the measures recommended by the FBI as consider some practical incident response measures.

What To Do Next

Beckage recommends that hospitals and healthcare providers implement several preventative steps to safeguard their organization including of the following measures: reviewing current incident response protocols and processes within the next 24 hours, and carefully crafting internal drafting internal and external messaging and FAQs with an experienced data breach attorney to help minimize legal risk as well as making sure employees know who to contact if they have reason to believe there is suspicious activity.

Beckage is available to discuss additional best practices that should be taken over the next 24 to 72 hours. Our team will continue to monitor this for new developments and provides updates as appropriate.  If an attack is detected and additional resources are needed, Beckage can be reached using our 24/7 Data Breach Hotline at 844-502-9363.

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COVID-19Insights Into the COVID-19 Health Data Bill

Insights Into the COVID-19 Health Data Bill

This update concerns the COVID-19 Health Data Bill, recently introduced to the New York State Senate by State Senator Kevin Thomas (S8448A), and in the State Assembly by Assemblywoman Linda B. Rosenthal (AB 10583). The COVID 19 Bill could have significant implications on businesses that collect information as part of their federal and state COVID-19 compliance measures, including the NYS-Required Safety Plans.  

The COVID-19 Bill applies to any company/person that collects, uses, or discloses “emergency health data,” which is defined to include data that is “linked or reasonably linkable to an individual or device, including data inferred or derived about an individual or device from other collected data” and that “concerns the public COVID-19 health emergency.”  

Emergency health data includes information that reveals past, present, or future physical or behavioral health or condition of, or provision of healthcare to, an individual including:

• data derived from testing or examination;

• whether or not an individual has contracted or been tested for, or an estimate of the likelihood that a particular individual may contract, such disease or disorder; or

• genetic data, biological samples, and biometrics.

Emergency health data also includes “other data collected in conjunction with other emergency health data that can be used to infer health status, health history, location or associations”. This includes: geolocation data, proximity data, demographic data, contact information, and other data collected from a personal device.  

The Bill requires businesses that collect, process, or use emergency health data in connection with the COVID-19 crisis to:

1. Obtain Affirmative Opt-In Consent: The Bill requires that businesses obtain an individual’s “freely given specific, informed, and unambiguous opt-in consent” to process individual emergency health data and prohibits collection without such consent except in certain narrow circumstances.

2. Comply with Data Retention Requirements: The Bill contains rigid data retention time periods (30 days or 14 days for proximity tracing or exposure notification data). If a business stores emergency health data for more than 30 days, The Bill requires the business to “reengage consent” from the individual from whom the information was collected in the first instance.

3. Maintain Written Privacy Policies and Transparency Reports: The Bill requires the posting of Privacy Policies which detail the business’s collection and use of emergency health data and the preparation of written Transparency Reports describing the business’s collection of emergency health data every 90 days.  

4. Limit Use: Data collected for responding to the COVID-19 public health emergency (e.g., tracking, screening, monitoring, contact tracing) must be collected “at a minimum level of identifiability reasonably needed for tracking COVID-19”. The Bill clarifies that for covered entities using proximity tracing or exposure notification, this includes changing temporary anonymous identifiers “at least once in a 10-minute period.” The Bill also prohibits the use of emergency health data for any purpose beyond what is adequate, relevant, and necessary to perform the transaction consented to by the individual, or for any purpose not authorized by The Bill (e.g., commercial purposes, advertising, selling, etc.).

5. Provide Individual Right to Access and Correction: The Bill gives individuals the right to access and correct their emergency health data.

6. Maintain Reasonable Security Measures: An entity that collects emergency health data must have reasonable administrative, physical, and technical controls in place to safeguard the information from misuse and unauthorized disclosure.

7. Maintain Minimum Necessary Access Restrictions: The entity must have access restrictions in place limiting access to the emergency health data to authorized essential personnel only.

8. Complete Compliance Audits: Covered entities are subject to data protection audits, which include the requirement for risk assessments and evaluation of the technologies used in connection with the information gathering. The results of the compliance audits shall be made available to the public.

The Bill also has notable enforcement teeth, authorizing the State Attorney General to bring enforcement actions and seek civil penalties of up to $25,000 per violation or up to 4% of a business’s annual revenue. As The Bill is for the purposes of the COVID-19 public health crisis, it purports to expire and be repealed on January 1, 2023.

To date, the bill is not on a committee agenda and there is no scheduled testimony for the COVID-19 Health Data Bill. It is not clear whether the bill will move through committee to the floor for a vote before the legislative session ends. However, we anticipate that legislators will be back in Albany at least a few more times this year, and Senator Thomas has been vocal in his desire to make progress on the Bill.

Beckage will monitor the progress on this and other relevant data privacy bills. Beckage is in communication with lobbyists and is closely monitoring for opportunities to provide input on behalf of the business community. Please do not hesitate to reach out if you are interested in discussing the bill’s potential impact on your business. Beckage is privileged to work with clients in a variety of sectors and industries in building efficient, repeatable, and scalable privacy and security programs.

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DoctorLegal and Practical Implications of the CMS and ONC Interoperability Rules

Legal and Practical Implications of the CMS and ONC Interoperability Rules

Beckage attorneys have been busy helping clients understand and prepare for the two rules concerning interoperability issued on March 9, 2020 by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) (collectively referred to as the “Final Rules”). The Final Rules implement interoperability and record access requirements intended to help patients obtain health records and payment data so they can make informed decisions about healthcare. To help de-mystify these technical rules, Beckage will be releasing a blog series outlining how the Final Rules will impact different organizations in the health sector.  

While future blogs will tackle some of the technical nuances of the Final Rules, this blog will provide some context by answering a few high-level questions:

1. Who should pay attention to these Final Rules? Healthcare providers, health IT developers, health information exchanges, health information networks, electronic health record (EHR) vendors, and insurers participating in CMS programs (for purposes of this blog, these stakeholders are collectively referred to as “health care organizations,” although as discussed in future posts, they often have different interests and obligations under the Final Rules).

2. What is an API? ”API” stands for application programming interface. An API is essentially a software intermediary that allows two applications to talk to each other using standardized language.

3. What does the CMS Final Rule cover? The CMS Final Rule requires states and certain health care organizations to develop APIs that allow patients, medical providers, and insurers to access specific categories of data. The rule is intended to improve patient access to health information and standardize the types of health information that can be shared. For example, patients will be able to request access to their medical records via third-party apps, and payers may deny access only under specific circumstances. The CMS Rule also requires payers to provide information about in-network providers and exchange information with other insurers in the event a patient enrolls with a new insurance company.

4. What does the ONC Final Rule cover? The ONC Final Rule imposes standardized protocols to allow networks and software applications to talk to one another. Basically, the ONC Final Rule requires insurers, medical providers, IT vendors, and health exchanges to speak the same language. This is accomplished through updated and standardized health IT certification requirements, data classifications, and systematic requirements for APIs. The ONC Rule also implements the information blocking provisions of the 21st Century Cures Act.

5. When will the rules take effect? United States Department of Health and Human Services (HHS) recently issued guidance stating that it was extending some enforcement deadlines. Below are just a few of the new compliance deadlines relevant to hospital and payer organizations:

·        Spring 2020: Hospitals must be able to demonstrate that they comply with patient admission, discharge, andtransfer (ADT) event notification procedures required by the CMS Rule.

·        July 1, 2021: Payers must make a PatientAccess API available so patients’ third-party apps can access medical records via the API.

·        July 1, 2021: Payers must make a Provider Directory API available, so patients know which providers are in network.

The Final Rules represent a complete overhaul of well-established standards and an introduction of new and highly technical requirements with compliance deadlines as early as Spring 2021. Now is the ideal time for health care organizations to assess compliance requirements, contract with vendors, and develop a compliance framework. Beckage attorneys are uniquely experienced to help health organizations and tech companies of all sizes to navigate the complicated maze of legal and practical considerations raised by these and other health law regulations.

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TelemedicineOffice of Civil Rights Empowers Health Care Providers to Provide Telehealth Services

Office of Civil Rights Empowers Health Care Providers to Provide Telehealth Services

On March 17, 2020, in light of the COVID-19 nationwide public health emergency, the Office of Civil Rights (OCR) announced that it will refrain from imposing penalties for noncompliance with HIPAA regulations in the context of good faith provision of telehealth. This significant Notification of Enforcement discretion allows health care providers to use“non-public facing” remote communications, such as audio or video communication technology, to provide telehealth to patients during this emergency environment. OCR clarified that the exercise of discretion applies to telehealth provided for any reason, not just for diagnosis or treatment of COVID-19. Providers may use video chat applications via phone or desktop computer, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype. However, “public facing” applications such as “Facebook Live,Twitch, TikTok, and similar video communication applications . . . should not be used in the provision of telehealth.” 

OCR encouraged providers to notify patients that these third-party applications potentially introduce privacy risks, and that they should enable all available encryption and privacy modes when using these applications. Although OCR will not impose penalties against providers for failing to execute a Business Associate Agreement (BAA) with the video communication vendors, OCR suggested that providers should nevertheless seek to provide telehealth services through HIPAA-compliant technology vendors that will enter into a BAA.

For more information about the telehealth Exercise of Discretion, see: https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html

Note that this is just one example of the discretion federal agencies may exercise in the context of a national emergency. See also: https://www.phe.gov/Preparedness/legal/Pages/phedeclaration.aspx for more information about regulatory discretion in the context of the Department of Health and Human Service’s recent Public Health Emergency Declaration.

Beckage attorneys, including our seasoned health care attorneys, are at the ready to help your organization navigate the use of telehealth services during these unprecedented times. Our experienced team understands the nuances associated with the intersection of healthcare, law and technology and can provide practical know-how related to the provision of telehealth services.  

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