Hello everyone

I assume this is being recorded

Thank you John Kanskey, Leslie Lenert, Brett Oliver, James Pantelas, Raj Ratwani, Abby Sears, Denise Webb. You all are family, forever. Your service is invaluable and thank you for everything and being amazing professionals and friends.

🙏🙏🙏

Fabulous choice!!

Woohoooo! Thank you, Medell!

Congrats Medell!!!

Congratulations to all! Thank you for your service!

Thank you to all of the outgoing HITAC members. It has been a pleasure to work with all of you.

Denise, you have been an incredible leader. Your presence will be missed. Thank you for your leadership!

Approve

It would be SO nice to again meet in person in 2023.

@Steven - completely agree. Here's to hoping!

Agree!

Woohoo at Pharmacy interop!!! So important

Great to see pharmacy interoperability on the work plan for 2023!

Yes-Excited about Pharmacy group!

Yay - Pharmacy interoperability!!

Especially when it comes to pediatric pharmacy interop. This is so critical and difficult but tremendously impactful to double click on

Pharmacy has been an interoperability leaders for years!

Is there an opportunity for certification of pharmacy IT systems to support greater integration?

the pandemic has really highlighted the role pharmacists can play with clinical services and public health. Completely agree with Tricia Lee in many cases data is unavailable for pharmacists to support this

We need consistent capture and exchange of discrete sigs and diagnose/indication data associated with prescriptions.

*diagnosis

Les Lenert here…apologies for being a few minutes late

Yes @Steven Lane - NCPDP has the standards to capture the information for diagnosis, indications, etc. but also need the upstream prescriber to send that through the EHR and eRX system

pharmacists can prescribe Paxlovid, but need lab records to do so. Another example of where interoperability is important

#RealWorldEvidence, #ADE data, research, FDA engagement…. So many opportunities!

So needed. One simple improvement - I would love for an electronic discontinuation for a medication actually be received by a pharmacy. In my state, <1% of pharmacies have that functionality turned on.

+1 Steven Lane

Incentivize documentation of Reason for Discontinuation

This space is an enormous need. The amount of manual paperwork and fax my clinic does to prescribe DME like continuous glucose monitors is unbelievable..

Totally agree Steven. We need to break down barriers in willing to share indication and standard SIG codes on the eRx.

+1 Aaron

It absolutely should, Deven.

PGx lab results is another area where pharmacists can play a role - how do we capture and share that information in a standardized way?

Direct to Consumer Med services - this is where we are still needing some way of positive patient identification / unique patient identification!

Direct to Consumer also needs further med reconciliation functionality as well.

+1 Aaron

Prescribing pharmacists must be enabled/supported with more complete access to patients’ medical histories to inform their prescribing.

+1 Medell

Thank you Tricia Lee!

Friendly public comment when it might be useful before a HITAC vote: Add consideration in 2023 of *write-access FHIR APIs* to facilitate patient-generated health data, integration of SDOH data, patient-reported outcomes, etc. Needed for so many critical national use cases!

+1 Steven Lane

+1 Medell+1 Steven

Great job Tricia....really exciting to hear your passion for pharmacy and looking forward to our working together.

Agreed Mark.

+1 Lee Ann

+1 to Mark Savage’s suggestion

We definitely need to put efforts to address this longtime missing link (pharmacist role in public health).

+1 Pam

For pharmacy, should also consider bilateral access to med/clinical history — access to history could additionally help REMS rx….

+1 Mark Savage re: PGHD, PROs, etc.

+1 Mark Savage

+1 for Mark's comment.

+6 to Mark Savage

Arien - there is some great collaboration work today happening between the HL7 accelerator Codex, NCPDP and the FDA on a REMS use case

Would like to second Steven Lane’s question around certifying pharmacy IT systems.

Yes Hung. Good point and need for us to seek a balanced approach.

Pharmacy health equity is critical. +1 to Hung

Very important points, Hung.

+1 to Hung!

I hope that as we consider direct to consumer that we are considering educational levels, English as a second language

We are challenged on many fronts to strike a balance between the desirability of interoperability and the need to respect privacy.

+ interstate prescribing and dispensing

Glad people are bringing this topic up. In particular in the post-Dobbs era, when it comes to pharmacy related data sharing, this is a HUGE topic for ONC leadership.

+1 to Cynthia, was going to comment on the same-ability of pt to control who sees what and when

Great discussions!! - NCPDP’s Strategic Planning Committee as well as through standards development in task groups and work groups have been executing on goals to advance the role of the pharmacist and the sharing, exchange, access and use of clinical information to support advances in patient care.

Agree completely on interstate prescribing and dispensing….we are really struggling to manage and protect patients AND providers when our data is moving across state lines

Not just Athena….that happens often in many places

We do not have sufficiently “surgical” tools today that allow patients to opt out of the exchange of a subset of their medication (or any other class of) data from clinicians, HIEs or other data holders. This functionality should not be limited to meds prescribed by clinical pharmacists.

Completely agree — digital signatures are now an all or nothing with no reasonable opportunity to read or negotiate the Ts&Cs to which patients assent.

Correct Alexis. I dont think it's a technology specific challenge but a universal industry wider issue that you're seeing come out in the technology (e.g.: need for some standards to help drive the right technical outcome)

Agreed Steven. It'll be interesting how best to simplify the process of opt-in/opt-out across the patient record.

Great comments - public health ecosystem

and how's that's handled longitudinally. if someone opts in initially, can they truly opt-out later?

And needs to be in Language of choice

Don’t think HITAC has done much on privacy issues - sounds like 2023 is the time 🙂

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+1 Deven. Privacy and Consent

@Cameron - (Please direct your comments to Everyone so they become part of the public record.) As pharmacists, at least Clinical Pharmacists, are Clinicians and part of the care team, they are/should be subject to Information Blocking prohibitions and therefore required to share their data with other pharmacists and all members of the treatment team.

Thank you for your time, and very thoughtful comments and discussion.

I suspect the consumer experience post GDPR is a likely preview of how more granular consent might work in practice, e.g. the splash screen many websites now include about which cookies to accept. Interested in perspectives as to whether this is a desirable outcome.

There are definitely better approaches to privacy than what has been mandated in the case of cookies. Consent is important - but too much reliance, without any mandated safeguards required to be implemented by data holders, pushes the entire burden of privacy onto the patient.

Re ONC action on Privacy, I believe that we are still awaiting an FAQ regarding actors’ ability to establish policies requiring patient authorization for the sharing of certain highly sensitive data (e.g., sexual and gender-related care) without running afoul of the Information Blocking prohibitions. This would be incredibly valuable for providers and others interested in protecting patient privacy while supporting needed interoperability.

I actually think it’s pretty clear in the guidance published with the final rule, as well as the privacy safe harbor description, that voluntary consent policies - if fairly applied - fit into that safe harbor.

But greater attention to what has already been published - and some further clarity of any remaining uncertainty - would be valuable.

It has been some time since ONC has provided grant support to the PP2PI/Shift effort to develop standards and workflows to support granular privacy controls. It would be helpful for ONC to schedule a report out to HITAC on this important work to see the fruits of this public investment and the hard work that has been done to date.

…especially in light of the overlap with Pharmacy Interoperability as discussed earlier.

There are a number of potential improvements in providing pop Stoney’s better information about what they are signing, including more details about opting in to data for research use, specifying whether the data will be identified, for example. I, personally, have a rare condition, making my data interesting. I generally don’t have an issue with my data being used, especially when used to develop medications or treatments for my condition. I would like more information in my consent regarding what is the scope of any particular project using my data, the involved organizations, and investigators.

—correction: providing better information

Please omit “Stoney’s”

Huge thanks to the co-chairs, members, and staff that led to these Public Health recommendations. It is notable that these recommendations represent a first step toward rationalizing and improving the exchange of data between providers and PH. In time it would be beneficial to revisit the opportunity to certify the functions of of PH data systems and programs themselves to define a floor of functionality and service that everyone across the country deserve. Such standardization would also benefit and lower burdens on providers who inevitably must interact with multiple PH jurisdictions given the mobility of the population.

Improving standardization of lab-related data exchange should have positive impacts for many entities- including ordering providers, laboratories, and public health (both laboratory services and use of laboratory test results data).

In the detail for cancer registries, we noted overlap between research objectives and cancer registry reporting, including MedMorph and OMOP.

Excellent work.

What about self-reported tests (e.g. at home covid rapid test)?

Thank you Arien and Gillian and TF members for the detailed, comprehensive, and very throughtful report!!

Congrats Jillian & Arien!!!

than you too all!

FDA would be an appropriate partner for USCDI+

This too may align with ONC efforts to advance Pharmacy Interoperability and Emerging Therapeutics.

It would help to know the types or categories of information blocking complaints against providers to determine if more education or other support is needed to assist providers in complying with the requirements of information sharing.

Great suggestion Denise. Understanding the common themes would be valuable!

+2 Denise! HITAC could provide input on the categorization scheme. My understanding is that ONC is open to inviting submitters of complaints to categorize their submission and to report that out with their metrics.

+3 Denise. Also it would be nice to sort by entity that has multiple complaints versus singular. Could provide a view into themes that need further education or clarity

It would be helpful to extend these nationwide metrics to include tribal and territorial jurisdictions in addition to the 50 states.

We should also note that much of, e.g., the iz work is primary/ambulatory rather than hospital based.

So really useful to get a hospital survey but we should remember that’s one piece of the puzzle.

It would be helpful to track evolution of technical transport methods for reporting - SFTP, V2, C-CDA, FHIR, etc.

This is fascinating data to guide and inform the HIT infrastructure needs to support rural and under-resourced areas. Thank you!

Also, we all look forward to the day that we can track the uptake of query capability on the part of PH jurisdictions to allow them to query for supplemental information (via IHE/QBDE, FHIR, etc.) as needed after receiving these reports.

Thanks John… agree. Depends on person at hospital or provider being aware of what they are actually doing

Yes, thanks all for the great suggestions to help us continue to improve our work!

This is fantastic and I whole heartedly support these HED recommendations. We leave people behind unintentionally by them not being seen through matching challenges, language challenges, transportation issues etc.

Are there any thoughts about how to continue to drive for broad band access nationally in every part of our Country?

Consider how to coordinate with NIH - Aim Ahead project that is funded to work on this explicitly.

Backing up a little, we probably need to survey public health authorities on data exchange with providers. There needs to be very clear understandings of what data are being exchanged for what purposes. A ELR message is not an eCR message. The contents of the two message types may differ substantially.

Improvements in laboratory-related data exchange (use of and adherence to interoperability standards) could be added as a substantial goal

A Privacy Policy & Patient Directives infrastructure should be tracked beyond TEFCA as much cross-organizational exchange will continue to occur for a substantial time outside of TEFCA and we need to cover this ability regardless of how data is being asked for or shared.

Really appreciate the discussion of data suppression and segmentation! Apologies if I missed this, but was there discussion about 42 CFR Part 2 use cases and SUD data security?

Exactly….

Exactly!

We are technically not able to handle the nuances related to women’s health segmentation.

shameless plug: https://www.healthit.gov/buzz-blog/information-blocking/information-blocking-eight-regulatory-reminders-for-october-6th

Agree and a big plug for interoperability between public health and Medicaid!

And, reminder that public health agencies are often not HIPAA-covered entities

+1 to Medellin and Ike

Medell (autocorrect)

had my hand raised