Health Data, Technology, and Interoperability Rules, HTI-1, 2, & 3

Health Data, Technology, and Interoperability Rules, HTI-1, 2, & 3

by | Dec 16, 2024 | , , ,

The landscape of health IT regulation just took another significant leap forward. In the final days of 2024, federal regulators dropped two game-changing rules—HIT-2 and HTI-3—adding to the foundation set by HTI-1. Together, these regulations are reshaping how healthcare organizations approach interoperability, data sharing, and compliance in an era of rapidly evolving technology. But what do these latest rules really mean for healthcare providers, developers, and patients? Let’s break down the impact and key takeaways you need to know.

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Lessons Learned from Real Time vs. PointClickCare: Mind your Information Blocking Ps and Qs

Lessons Learned from Real Time vs. PointClickCare: Mind your Information Blocking Ps and Qs

by | Aug 16, 2024 | , , , ,

A federal district judge has granted preliminary injunctive relief to Real Time Medical Systems, Inc. (“Real Time”) barring the defendant, PointClickCare (“PCC”), from deploying unsolvable CAPTCHAs that interfered with Real Time’s ability to access the data of its skilled nursing facility customers that utilized PCC. As Judge Xinis wrote in the opinion, “No evidence supports that PCC had any legitimate good faith use for wholly inscrutable CAPTCHAs which, by definition, blocked Real Time from getting the very records it needs to exist….But even more damning is the timing of such deployments, which support that PCC used those CAPTCHAs as a device to hamstring or eliminate Real Time as a competitor.” Keep reading for additional details regarding Real Time’s complaints against PointClickCare.

Update: On August 19, 2024, PointClickCare filed a Motion to Expedite Appeal with the United States Court of Appeals for the Fourth Circuit.

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Hefty Monetary Disincentives Proposed for Health Care Providers Engaged in Information Blocking – But Not Every Provider Is on the Hook.

Hefty Monetary Disincentives Proposed for Health Care Providers Engaged in Information Blocking – But Not Every Provider Is on the Hook.

by | Oct 31, 2023 | ,

The Proposed Rule for enforcement is out, and the potential financial “hit” that health care providers may face if the OIG finds them to have violated the Information Blocking Rule (IBR) could be substantial, but don’t get spooked. The reach of the proposed enforcement has limitations. Read more to find out why.

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Penalties for Violation of the Information Blocking Rule Start Today!

Penalties for Violation of the Information Blocking Rule Start Today!

by | Sep 1, 2023 | ,

OIG’s authority to begin enforcement of the Information Blocking Rule begins September 1, 2023. Certain Actors subject to the Information Blocking Rule may be subject up to a $1 million penalty per violation! Actors need to be proactive in ensuring their compliance with the Information Blocking Rule and not wait for the OIG to discover them.

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ONC Says “Vetting” Mobile Apps is Information Blocking

ONC Says “Vetting” Mobile Apps is Information Blocking

by | May 2, 2023 | ,

ONC says actors that require third-party apps to be “vetted” by them for security reasons before allowing patients to use such apps to receive EHI via API technology certified to the Standardized API certification criterion is likely to be information blocking. However, my concern with relying solely on the security criteria required for API certification is that it is too low of a bar to adequately protect patients and other individuals from developers of apps that fail to keep promises to keep individuals’ information confidential.

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ONC Publishes New FAQs on Information Blocking focused on the Privacy Exception.

ONC Publishes New FAQs on Information Blocking focused on the Privacy Exception.

by | Apr 2, 2023 | , ,

The Office of National Coordinator says it receives a lot of questions regarding how the Information Blocking Rule is supposed to work in tandem with the HIPAA Privacy Rule and other federal and state laws governing privacy and confidentiality. Their new FAQs aim to help clarify when actors can choose to not respond to a request for access, exchange, or use of electronic health information.

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ONC Vindicated. Patients Want Immediate Access to Test Results

ONC Vindicated. Patients Want Immediate Access to Test Results

by | Mar 24, 2023 | , ,

JAMA published a study earlier this week finding more than 95% wanted immediate access to test results. However, when speaking to ONC, the study’s lead researcher specifically noted that although 95.3% of patients who received abnormal test results responded that they still would like to continue to receive immediately released results, this was associated with nearly twice the likelihood of worry compared to respondents who received normal results.

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FTC Orders BetterHelp Health App to Pay $7.8M for Sending User Data to Facebook & Snapchat

FTC Orders BetterHelp Health App to Pay $7.8M for Sending User Data to Facebook & Snapchat

by | Mar 2, 2023 | , , ,

The FTC issued a proposed order requiring BetterHelp to pay $7.8 million to consumers to settle charges that it shared consumers’ health data with Facebook, Pinterest, Snapchat, and Criteo after promising to keep such data private and claiming it is “certified” as “HIPAA compliant.” The real juice of this case is in the FTC compliant — and HIPAA-covered providers, facilities & organizations can learn a lot about what to watch out for with health data Apps as we continue to march towards the FHIR.

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When Does a Health Care Provider Wear an HIE/HIN Hat for Purposes of the Info Blocking Rule?

When Does a Health Care Provider Wear an HIE/HIN Hat for Purposes of the Info Blocking Rule?

by | May 5, 2021 |

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.

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What Information Must be Made Available on Patient Portals?

What Information Must be Made Available on Patient Portals?

by | Apr 8, 2021 |

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 …..

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Information Blocking Compliance — So What Happens on April 5th?

Information Blocking Compliance — So What Happens on April 5th?

by | Mar 25, 2021 |

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?

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NEW ONC FAQ: Prior Agreements or Contracts CAN Implicate Information Blocking as of April 5th!

NEW ONC FAQ: Prior Agreements or Contracts CAN Implicate Information Blocking as of April 5th!

by | Mar 19, 2021 | ,

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.

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How to Use the Privacy Exception to Deny an Abuser Access to EHI

How to Use the Privacy Exception to Deny an Abuser Access to EHI

by | Mar 5, 2021 | ,

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.  

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Checklist for Info Blocking Compliance

Checklist for Info Blocking Compliance

by | Feb 25, 2021 |

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 . . .

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