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Written by Catriona Coffey. 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. Information Blocking Section 4004 of the Cures Act prohibits “information blocking,” or any practice by a health IT developer of…
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…
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…
Late last week, two new proposed rules were released which will affect the exchange of health information and HIPAA, among other things.  The CMS and OCR proposed rules come in at over 347 and 357 pages respectively – so that’s a lot of meat to digest!  At a high level, the CMS Proposed Rule aims to “improve the electronic exchange of health care data among payers, providers, and patients,” and “streamline processes related to prior authorization to reduce burden on providers and patients.” The OCR proposed changes to HIPAA take a bite out of patient access, minimum necessary, the HIPAA…
On Monday, ONC posted a new Information Blocking Frequently Asked Questions resource!  Here are a few of the highlights from all of the FAQs responded to by ONC: Q:  Are health plans or other payers subject to the information blocking regulation? Q: For the period of time when Information Blocking is limited to USCDI data, how is an Actor expected to fulfill a request for USCDI data if they do not yet have certified health IT in place that includes an API with the USCDI standard? Q: Is an Actor required to fulfill a request for access, exchange or use of EHI with all…
Interim Final Rule with Comment Period Responds to COVID-19 Pandemic. Responding to public health threats posed by the coronavirus pandemic, today the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health IT (ONC) released an interim final rule with comment period that extends the compliance dates and timeframes necessary to meet certain requirements related to information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements.…
ONC’s final rule on Information Blocking implements the 21st Century Cures Act and fleshes out what is and is not a prohibited information blocking practice.  However, not all health care organizations and their vendors are on the hook for complying with this new regulation. In my post today, I want to drill down on the scope of health care providers that must comply with the Information Blocking Rule.…
As the November 2nd deadline for compliance with ONC’s Information Blocking Rule nears, many health care providers – which are “Actors” subject to the Rule – are scrambling to reexamine their default settings for sharing various types of data, including lab results. In ONC’s Final Rule preamble, several commenters indicated that providers’ current organizational policies call for practices that delay the release of laboratory results so that the patient’s clinician has an opportunity to review the results before potentially needing to respond to patient questions, or has an opportunity to communicate the results to the patient in a way that…
Join me for a pair of 1.5hr Information Blocking Workshops designed to work thorough the nitty-gritty details of the Information Blocking Rule.  The first Workshop will take place WEDNESDAY (9/30) so don’t delay! Workshops will include use cases and scenarios aimed at real challenges faced by health care providers looking to comply with these new regulatory standards for access and sharing of electronic health information. Registrants will receive 2 sample P&Ps, and much more!…
Yesterday, all at once, OCR announced that it has entered into five new Resolution Agreements — each of them stemming from one or more violations of HIPAA’s right of  access afforded to individuals. There are several interesting observations about these new cases that are worth taking note of. First, although the “penalty” amounts are relatively low, OCR is still definitely intending to set a clear expectation about patients’ right of access afforded under HIPAA. The amounts in these new cases ranged from $3,500 on the low end, which OCR assessed against a psychiatrist in Virginia, and went up to $70,000,…
At the last hour, CMS extended the deadline for publishing much anticipated changes to the Stark Law. Originally expected for publication this past August, CMS extended the deadline to August 2021, noting that “… we are still working through the complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date.” Together with the OIG’s counterpart rule, the proposed rules contain the potential for significant modernization of the Stark Law and Anti-kickback Statute as part of the “Regulatory Spring to Coordinated Care” as well as increased…
Seton Hall Law’s Institute for Privacy Protection and Gibbons Institute of Law, Science & Technology is hosting a Virtual Event on September 17th with legal academics, practitioners, and government officials who will evaluate the impact of the COVID-19 pandemic on privacy and intellectual property. Panel One speakers will discuss balancing privacy & public health; Panel Two will discuss Intellectual Property – incentives to access to vaccines & treatments.…
After over almost four months of no new HIPAA Resolution Agreements or Civil Money Penalties, OCR quietly posted two new HIPAA settlement agreements at the end of July.  At first glance, both appear to be “run-of-the-mill” cases with nothing much new to learn with the first one resulting in OCR finding that the covered entity failed to even complete a basic Security Risk Analysis and training of workforce, and the other involving – yes, yet again – a stolen unencrypted laptop.  However, the second case in particular deserves closer examination where it has embedded in it more complex corporate structure…
Yesterday, the period for public comment on the FTC’s Health Breach Notification Rule closed.  The FTC’s Health Breach Notification Rule requires vendors of PHRs and PHR-related entities to notify the FTC if they experience a breach of security involving unsecured health information. Another area of change to Breach Notification is arising out of the CARES Act which was was enacted into law on March 27, 2020 and is making significant changes 42 C.F.R. Part 2.  Among other changes that the CARES Act is introducing, it creates an entirely new obligation on Part 2 providers to notify SAMHSA of uses and disclosures of Part 2…
The award will allocate $2.5M to fund up to 5 awards (in the amount of up to $500K EACH) with a period of performance of up to 2 years in the form of cooperative agreements with funding contingent upon availability of funds, satisfactory completion of milestones, and a determination that continued funding is in the best interest of the federal government and the public. SHORT TURN AROUND! Deadline is September 1, 2020 to get Applications in.…