Mind your Breach Insurance and Vendor Contracts
A preliminary class action data breach settlement involving UnityPoint Health should prompt health care organizations to take a second look at their breach insurance coverage as well as their contracts with vendors who process data on their behalf. Adequate cyber and breach insurance coverage is paramount and should be commensurate with the health care organization’s size, operations. Additionally, health care organizations should pay close attention to their vendor contracts, particularly limitation of liability clauses, hold harmless provisions and indemnification provisions in health IT and other contracts.
Don’t Wait to Understand How “FHIR” Will Transform Health Information Exchange, or You’ll Feel the Heat When it Ignites!
CMS & ONC have promulgated their Final Rules to implement the 21st Century Cures Act. A main goal is to accelerate the access, exchange and use of electronic health information (EHI). One way this is being accomplished is to require certain entities and actors to provide Application Programming Interfaces (APIs) that use a new standard for data access and exchange called Fast Healthcare Interoperability Resources (aka “FHIR”). These new standards for adopting FHIR for information exchange is expected to exponentially accelerate individuals ability to access and share EHI through mobile apps, as well as allow any third-party adopting such FHIR standards to obtain access to such EHI. Especially for HIPAA Privacy Officers, Security Officers, Compliance Officers and attorneys who have for years focused on ensuring that their organizations do not make the mistake of releasing protected health information to a third-party in violation of federal or state privacy and security laws, I feel your pain on FHIR!
You Should Know Your Affirmative Defenses if OCR Investigates You for HIPAA Violations
The HIPAA Enforcement Rule prevents the Secretary/OCR from assessing civil monetary penalties (CMP) against a covered entity or business associate if an Affirmative Defense can be established. A HIPAA violation that is corrected within 30 days of discovery can potentially insulate an organization from CMPs, provided certain requirements are met. But an organization has to make sure that it fits squarely within the requirements of these regulatory defenses to be fully insulated.
Don’t Miss CMS’s Engagement Calls for Ongoing COVID-19 Developments
Need access to current information about COVID-19 and Medicare? CMS is holding stakeholder engagement calls to provide an opportunity for hospitals, health systems, and providers. The Webcast sessions are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.
CMS Issues Telehealth Encounter Guidance for Quality Reporting Programs
New telehealth encounter guidance is available for the Promoting Interoperability Programs and Quality Payment Program. There are 42 telehealth codes eligible for inclusion within the eligible professional/eligible clinician eCQMs for the 2020 performance period. For the 2021 performance period, 39 telehealth codes would be eligible, however, there are also additional eCQMs identified as not eligible for telehealth encounters.
Why Privacy & Consent Will Remain a Central Hurdle to Health Info Exchange Despite the Info Blocking Rule
Under the Privacy Exception, an Actor is permitted to not fulfill a request received to access, exchange, or use EHI to protect an individual’s privacy. The sub-exception for a “precondition-not-satisfied” will continue to put state laws governing privacy and consent at the center of decisions about whether EHI will be shared with third parties. Healthcare providers and HIEs/HINs especially will need to ensure that they have identified and analyzed each legal precondition to the release of EHI that is applicable to the particular type of entity and type of information that is implicated.
Is Your Organization Ready to Send Patient Information to Apps by November?
Becker’s Hospital Review reported that 70% of CIOs are “concerned” about meeting the upcoming November 2nd deadline for complying with the Final Rules prohibiting information blocking practices. This is according to a survey conducted by CHIME, which included responses from executives at academic medical centers, critical access hospitals, multi-hospital systems and specialty hospitals. Although the survey did not appear to identify specifically what concerns CIOs about complying with information blocking rules by this fall, one possibility is fully understanding how ONC’s information blocking rules will apply to releasing patients’ EHI to third-party apps.
FDA issues COVID-19 Guidance for IRB Review of Expanded Access Requests; Updated Clinical Trial Conduct Considerations
The FDA has issued guidance for IRB review of...
WEBINAR: Learn Which HIPAA Policies to Revise for ONC’s New Information Blocking Rule, Plus More!
Join the NJ Chapter of HIMSS and Helen Oscislawski for this Webinar to get a lean and focused overview of what you need to do to comply with ONC’s and CMS’s final rules implementing the 21st Century Cures Act. On April 24, 2020, the OIG also released its Proposed Rule on CMPs to be imposed against Actors who engage in prohibited “Information Blocking.” These new rules turn on their heads certain HIPAA policies and procedures.
Threading the HIPAA Needle through Information Blocking to Block Patient Access when Data is Corrupted
The Information Blocking (IB) Rule is intended to work in sync with HIPAA, including the “right of access” the Privacy Rule grants to patients with regard to access to their own protected health information (PHI). However, as I continue to analyze how to implement various standards that overlap between these two regulations, questions about how to thread the needle on seemingly conflicting standards continues to come up. Today, I take a closer look at the difference between HIPAA’s “right of access” as compared to the Preventing Harm Exception found in the IB Rule. Specifically, this post considers how a covered entity health care provider . . .
How the Preventing Harm Exception Changes HIPAA
the “Preventing Harm Exception” under the Information Blocking Rule is not only the most challenging exception to apply, but also the most difficult to interpret – particularly where some of the standards do not exactly track HIPAA, and still other imprecise language ONC used has made its interpretation uncertain. In this post, I will attempt to distill the Preventing Harm Exception down to its basic elements, as well as point out issues in its interpretation to be aware of.
Fifth Circuit Vacates $4.3M MD Anderson Penalty
The Court of Appeals for the Fifth Circuit vacated the $4.3M penalty imposed on M.D. Anderson as arbitrary, capricious and contrary to law.
A Look Ahead to 2021
The new year has much in store for electronic health information exchange compliance! Today’s post provides an overview of anticipated changes to the health information regulatory landscape in 2021, including increased interoperability efforts and telehealth expansion due to the coronavirus pandemic. It is not surprising that many of the topics discussed below are a direct result of the interoperability requirements created by the 21st Century Cures Act (“Cures Act”) enacted in December 2016.
Our Stockings are Stuffed with Compliance Tools
Seasons Greetings to all of our readers! First, we want to wish you and yours a holiday season filled with health, happiness and hope! We also want to thank you all for continuing to make Legal HIE such a popular and highly visited blog! It puts a smile on our face seeing so many of you enjoying our posts and returning to our site often!
As stockings are being hung by chimneys with care, we want to make sure you know that Legal HIE’s stockings are absolutely stuffed to the brim with tremendous tools, sample forms, polices and turn-key solutions that can help your organization stay on top of the most pressing compliance challenges, and ever-changing healthcare regulatory landscape. 2021 promises to be a year with many new and final regulations going into effect, and being released. The Legal HIE compliance library was created specifically for this purpose – to help busy and overwhelmed compliance officers and attorneys keep up with these changes by offering turn-key samples and solutions as a solid starting point.
OCR Publishes New Guidance on Sharing PHI through HIEs for Public Health Purposes
Last Friday, the Office for Civil Rights (OCR) issued new Guidance on how HIPAA permits covered entities and their business associates to use health information exchanges (HIEs) to disclose PHI for the public health activities of a Public Health Authority (PHA). Specifically, it provides examples relevant to the COVID-19 public health emergency. OCR Director, Roger Severino, specifically notes that the Guidance was issued:
“to highlight how HIPAA supports the use of health information exchanges in sharing health data to improve the public’s health, particularly during the COVID-19 public health emergency.”.
Although much of the Guidance document simply reiterates the controlling HIPAA Privacy Rule provisions and definitions which have always afforded a mechanism through which covered entities (CE) and their contracted business associates (BA) can share ePHI with a public health authority for public health purposes, there are a few notable new take-away nuggets.
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