The forecast for Arizona is thunderstorms, at least for at least one health care system. Last week, OCR announced a $1.25 settlement for HIPAA Security Rule violations brought to light by a cybersecurity hacking incident that took place over five years ago.
The chickens have come home to roost for GoodRx. The FTC has assessed a $1.5 Million penalty against the telehealth and prescription drug discount provider for failing to report unauthorized disclosures as required by the Health Breach Notification Rule.
On December 1, 2022, OCR released a “guidance” Bulletin re: “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.” From it, we learned (among other things) that OCR believes that an individual’s IP addresses and geo location, collected by a regulated entity’s website, is protected by HIPAA. Now, we have come to learn that HIPAA compliance investigations by OCR are already underway concerning this topic. Are you ready?
The New Year is finally here, and I believe that there will be a LOT going on in 2023! Here are just a few of the things that Legal HIE is looking to stay on top of for our readers this year . . .
SAMHSA finally fulfilled its duty under the CARES Act & releases a Proposed Rule “Confidentiality of Substance Use Disorder (SUD) Patient Records” amending the Part 2 rules in line with the CARES Act’s requirements. This is the 4th overhaul of the Part 2 Rule in 5 years…
Today, the Information Blocking spigot has officially opened. The Content & Manner Exception no longer applies; now, all electronic health information (EHI) cannot “blocked” if requested (unless another exception applies).
As efforts at the federal and individual states level evolve every day at almost a breakneck pace to address challenges and needs related to the COVID-19 outbreak, here is a updated running list of some of the top actions taken at the federal level that we thought would be helpful to the healthcare industry (Caveat, this is not an exhaustive list):
Under the Information Blocking Rule (IBR), a health information network (HIN) or health information exchange (HIE) type actor is one that “determines,” “controls,” or has the “discretion to administer” access, exchange or use of EHI between two or more unaffiliated entities. ONC has said that a separate entity is not necessary to trigger the IBR HIN/HIE definition of an Actor. Additionally, ONC has specifically pointed out that a health care system, for example, could wear two IBR actor hats: (1) as a health care provider, and (2) as a HIN/HIE.
Well folks, the Information Blocking Rule (IBR) April 5th compliance deadline is behind us at this point. However, I know that many of you are continuing to work through your top IBR challenges and questions one at a time. At this point, I have worked through many thorny IBR issues with numerous health care providers and health information exchanges (HIE), so I thought it might be interesting for me to share what is the main topic that I see Actors are focused on. And the winner is …..
The deadline for compliance with the Information Blocking Rule is just 12 days away! I am certain that all the Actors are working feverishly and diligently to come into compliance with these new requirements by this fast-approaching date. On the bright side, I suppose that we can all be relieved that ONC did not stick with its original deadline date of November 2, 2020. However, even with the extra time Actors may still be scrambling to get all of their ducks in a row by April 5, 2021. So, what are the actual consequences if everything is not “buttoned-up” in time?
On and after April 5, 2021, any actor’s agreements, arrangements, or contracts are subject to and may implicate the Information Blocking Rule. The Communications Condition of Certification (CCOC) requirements must be revised to remove or void the contractual provision that contravenes the CCOC requirements whenever the contract is next modified for any reason. A Business Associate Agreement should generally not prohibit or limit the access, exchange, or use of the EHI for treatment.
When an Actor wants to potentially deny access of EHI to a person who is suspected of some type of abuse of the individual (the “Abuser”) whose EHI is being sought, the natural inclination is want to look to the Information Blocking (IB) Rule’s Preventing Harm Exception to justify such denial. However, the IB Rule’s Privacy Exception offers additional options and, in certain ways, more flexibility for the Actor to deny a suspected Abuser’s request for EHI.
Over the last few weeks, I have come across a number of health care provider organizations that are under the incorrect assumption or belief that their EMR vendor is “taking care of” all that needs to be done in order for the provider to comply with Information Blocking. This is false. There are operational decisions and other process issues that must be addressed and can only be implemented by the Actor. Every health health care provider that meets the definition of an “Actor” should be taking active steps towards getting their organization positioned to comply with Information Blocking by April 5, 2021. Where should you start? I propose using a checklist as a simple starting point to begin “ticking off” your Information Blocking “to do” list . . .
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 . . .
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.