Blockchain Development Services for Healthcare Providers: How to Pick the Right Partner

Healthcare leaders are getting pretty fed up with all the hype around "blockchain for everything." What they really need is a straightforward, regulation-savvy game plan to understand whether a distributed ledger can help save money and reduce risks. And if it can, they’ll want to find the right partner to help make it all happen. This guide gives you the lowdown on what to expect from the regulatory landscape in 2026. We’ll shine a light on the best use cases out there and share a handy checklist to help you pick the right partner. Plus, we've included some insights on implementation and the important metrics, or KPIs, to keep an eye on along the way.

If you're in healthcare decision-making, you've got some important things to keep in mind! It's all about understanding how the CMS's FHIR API requirements, the ONC's HTI-1 rule, TEFCA's roadmap, and the HHS's cybersecurity goals, along with the FTC's health app breach rule, can really impact your architecture. These guidelines and rules are definitely going to play a big role in how you structure your systems moving forward. On top of that, you'll have a solid understanding of the specific questions you should include in your RFP.

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Why 2026 is different: rules that drive your architecture

Before you dive into picking your vendors, take a moment to think about what you actually need. It's really important to base your requirements on the changes that are shaping how solutions are created and the timelines involved.

Hey there! Just a heads up - the CMS Interoperability and Prior Authorization final rule (CMS-0057-F) is making some big waves. It’s basically pushing certain payers to get on board with FHIR APIs. Exciting stuff, right? This covers the Patient Access, Provider Access, Payer-to-Payer, and Prior Authorization APIs. Heads up! There are some changes coming your way starting January 1, 2026. We're going to need everyone to get on board with API compliance, and that will be mostly required by January 1, 2027. So mark your calendars and stay tuned for more updates! They're setting up some new rules, including 72-hour and 7-day deadlines for decisions. Plus, they'll be sharing updates on PA metrics with the public. On top of that, there's a pretty cool benefit that lets you use FHIR-only prior authorization workflows while staying in line with HIPAA's enforcement discretion. This means you can skip the whole X12 278 requirement--just make sure you're sticking to the FHIR API rules! If your solution has anything to do with authorization or payer data, you'll want to ensure it checks off all the boxes for the new standards. It's super important that it lines up with the recommended HL7 Implementation Guides, such as CARIN Blue Button and Da Vinci PDex, Plan-Net, CRD, DTR, and PAS. Just a heads up! For more info, you can head over to cms.gov. There’s a lot of great stuff to check out!

The ONC's final rule for HTI-1 is definitely creating some waves! Starting January 1, 2026, USCDI v3 will be the new standard for certification. There's a bit of flexibility here since enforcement discretion is actually pushing some deadlines back to March 1, 2026. They're also changing things up by replacing the old CDS criteria with the new Decision Support Interventions (DSI). One cool thing about this update is that it comes with a transparency requirement for Predictive DSI, which basically means they’re diving into AI territory. If you're teaming up with someone, they'll have to demonstrate how their data models, APIs, and audit layers fit in with both the USCDI v3 requirements and the DSI timelines. For more info, swing by drummondgroup.com! You’ll find all the details you need there.

• TEFCA has officially moved beyond just being a title and is now all about live exchange! Plus, they've launched a fresh version of the FHIR Roadmap (v2). Currently, they’re testing out the QHIN-to-QHIN FHIR exchange, and we've also got the latest version of the Common Agreement, which is version 2. You've got the Standard Operating Procedures (SOPs) set up and running, and that includes Facilitated FHIR too. Hey there! If you’re diving into the national exchange scene, don’t forget to take a peek at your partner’s TEFCA strategy. It’s really important to look into their Designated QHIN integrations, see how ready they are for Facilitated FHIR, and check out their support for IAS. These factors can make a big difference! If you’re looking for more details, check this out here!

The HHS Healthcare & Public Health Sector Cyber Performance Goals (CPGs) highlight 10 essential controls that everyone should have in place, plus 10 additional measures for extra security. This includes a bunch of stuff like Multi-Factor Authentication (MFA), keeping your email secure, breaking up your network into segments, and having a centralized logging system. Get ready for some big-time attention from the board! It's super important to ensure that your blockchain projects really align with and back up your Zero Trust strategies. If you want more info, feel free to take a look at the article over on aha.org. It’s got all the juicy details!

Hey there! So, the FTC just introduced a new and improved Health Breach Notification Rule, and it’s going to shake things up for a lot of health apps and devices out there. So, if there's a data breach, make sure to mention any third parties who accessed the unsecured Personal Health Record (PHR) data. Also, don’t forget to stick to the new timing and content guidelines while you’re at it! If you're diving into a project that includes consumer apps or SDKs, it's definitely worth keeping HBNR on your radar. Even if you're already compliant with HIPAA, you don't want to overlook it! For all the juicy details, take a look at this link: (ftc.gov).

So, the DSCSA enforcement is set to kick in gradually from 2025 to 2026. There’s going to be a bit of a stabilization phase first in 2023 and 2024 to get everything lined up. Let's break down those important deadlines: if you're a manufacturer or repackager, make sure you're set to go by May 27, 2025. Wholesalers will need to be ready a bit later, by August 27, 2025. For the bigger dispensers out there, mark November 27, 2025, on your calendar, and smaller dispensers have a little extra time, with a deadline of November 27, 2026. So, get those reminders set! If you’re working in a hospital or involved with an IDN pharmacy, it’s super important to make sure your EPCIS systems are all set up. Plus, you need to establish some solid verification processes and workflows to handle any suspect products that might come your way. Using blockchain technology can seriously ramp up your audit trails and ensure that everyone is on the same wavelength. For more info, definitely head over to fda.gov. It’s got all the details you could need!

So, the Office for Civil Rights (OCR) just rolled out an updated bulletin on HIPAA and tracking technology. But here's the thing--some sections of that bulletin got tossed out by a federal court in 2024. It’s a bit of a rollercoaster, right? That said, it’s really important to avoid any unauthorized leaks, especially when it comes to pixels and cookies on secure pages. It's really important that you understand what the court decided to focus on--that's going to be crucial for patient-facing portals and analytics. (hhs.gov).

• Post-quantum cryptography (PQC): NIST has officially launched the PQC standards, which include FIPS 203 (ML-KEM), 204 (ML-DSA), and 205 (SLH-DSA). Now, the CMVP is working on incorporating these standards into their guidance. Hey team! Just a heads-up: vendors need to whip up a PQC roadmap. Imagine it as a mix of hybrid KEM for TLS and code-signing. Also, don’t forget to share your game plan for FIPS 140-3 HSM. We need to make sure we’re ready to move from 140-2 into that “historical” category by September 2026. Let’s get this done! (nist.gov).

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Where blockchain helps healthcare providers (and where it doesn’t)

Best-Fit Use Cases Where Distributed Ledgers Deliver Real Value:

1. Supply Chain Management
   Distributed ledgers have a great potential to boost transparency and traceability in supply chains. With blockchain technology in the mix, businesses can easily keep tabs on their products from the moment they’re made until they hit the shelves. This way, they can guarantee authenticity and cut down on fraud, which is pretty awesome!
2. Financial Services
   In the world of finance, distributed ledgers really speed things up and help cut down costs. They can really simplify things like cross-border payments and settlements, making them not just faster but also a lot more secure.
3. Healthcare Records
   Keeping track of patient records on a distributed ledger can really boost both security and accessibility. It’s a game changer! Patients have the option to give healthcare providers access to their medical records, all while ensuring their information stays safe and private.
4. Voting Systems
   Distributed ledgers have the potential to really enhance the transparency and security of voting. They can help ensure that the process is tamper-proof, making it easier for everyone to trust the results. They play a crucial role in making sure that every vote is counted accurately and that the whole process is fair and secure.
5. Digital Identity Verification
   Thanks to distributed ledgers, people now have a greater say in how they manage their digital identities. Basically, this gives people the power to decide what data they want to share and who they want to share it with. It's a great way to cut down on identity theft and boost privacy!
6. Smart Contracts
   These are basically contracts that run on their own, with all the terms and conditions coded right in. Distributed ledgers make it possible to automate and enforce contracts without needing any middlemen, which can save a lot of time and money.
7. Real Estate Transactions
   When you’re buying or selling a property, there’s a mountain of paperwork to deal with, plus a whole bunch of middlemen involved. Using distributed ledgers really helps to speed up transactions and cut down on the chances of fraud. It's a game changer for making everything run smoother!
8. Energy Trading
   In the energy world, distributed ledgers have the potential to make decentralized energy trading a reality for users. This lets people trade their extra energy directly, which is a great way to encourage the use of renewable energy.
9. Intellectual Property Management
   Artists and creators can totally take advantage of distributed ledgers to protect and handle their intellectual property rights. This makes it a lot easier to prove that you own something and keep tabs on how it’s being used, which ultimately helps you get paid fairly.
10. Loyalty Programs
    Distributed ledgers have the potential to really boost customer loyalty programs. Imagine being able to earn, redeem, and even trade your loyalty points across various platforms without a hitch. It's all about making the experience smoother and more connected for users!

All in all, distributed ledgers are set to shake things up across different industries by boosting efficiency, enhancing security, and building trust.

• Making sure provider information is accurate and that they're properly credentialed. By keeping everyone in the loop about demographics, practice locations, and endpoints, we really minimize the chances of unnecessary outreach and denials. The Synaptic Health Alliance just shared some exciting news: they've seen a real boost in returns on investment! Plus, they’re operating a network with multiple payers and providers, all thanks to the power of enterprise blockchain technology. This pairs really nicely with the HL7 Validated Healthcare Directory (VHDir) and Plan-Net, making for a smooth and standardized exchange. (synaptichealthalliance.com).
• Let's talk about being open about prior authorizations and keeping things in check with audits. Thanks to the mandates from CMS, a permissioned ledger is able to track every step of a prior authorization request and its response. This covers all the timestamps, reasons for denial, and any attachments, while the actual data flows through FHIR. It really simplifies metrics reporting and appeals, plus you won't have to deal with the headache of duplicating payload storage.
  (cms.gov).
• Hospital Pharmacy and DSCSA. If you start using ledger-anchored chargebacks and get your contracts in sync--like those MediLedger modules--you'll definitely see a big drop in revenue leakage. It's a smart move! On top of that, combining VRS and EPCIS really boosts verification and traceability. Plus, it keeps everything secure with a tamper-evident audit, so you can rest easy knowing everything's protected. Make sure you’re paying attention to the staggered FDA enforcement windows that are set to roll out in 2025 and 2026. (mediledger.com).
• Access to patient data and getting their consent.
• Combine W3C Verifiable Credentials (VC 2.

1. It's all about managing identity and consent using FHIR APIs. Just a friendly reminder: keep any Protected Health Information (PHI) off the blockchain. It’s best to store things like the status of your revocable credentials and consent receipts on-chain, but make sure they’re just in hash form. This way, you protect sensitive info while still keeping track of things! You can grab data from FHIR servers with SMART on FHIR. (w3.org).

When Not to Use Blockchain:

Blockchain is pretty revolutionary, but it’s not the best option for every scenario out there. Here are a few situations where it might be wise to pause and really consider if hopping on the blockchain train is the right move for you:

1. When Centralization Makes More Sense If you find yourself in a situation where a central authority can really handle things better, then it’s probably a good idea to go with that. For example, traditional databases usually handle speed and control much better.

1. High Transaction Volumes
   Blockchains can sometimes have a tough time when it comes to speed and scalability. If your app needs to handle thousands of transactions every second, like those high-frequency trading platforms do, you might want to explore some different options.
2. Simple Data Storage
   If all you really need is a simple way to store information and you don’t require a super secure, decentralized system, then a regular database will do the trick! Honestly, bringing blockchain into the mix just adds unnecessary complications. It’s really not worth it.
3. Private Data
   Blockchain is inherently public. If you're dealing with sensitive info that needs to be kept under wraps, sticking with a traditional database is probably your best bet.
4. Regulatory Compliance
   In industries that really need to stick to strict regulations, sticking with the old-school compliance systems might actually be the way to go. Blockchain can get a bit tricky, especially when you're dealing with data privacy laws.
5. Limited Adoption
   If your target audience isn't quite ready or willing to jump on the blockchain bandwagon, it might be a good idea to pause for now. Getting everyone on the same page for the shift to blockchain is super important for making it a success.
6. Cost and Complexity
   Jumping into blockchain can definitely get pricey and a bit complicated. If the perks don’t really stack up against the costs, then it might not be worth your time or money.
7. Lack of Expertise
   If you don't have the right skills on your team or can't seem to find the right talent to handle a blockchain project, you could be running into more headaches than it's really worth.

At the end of the day, blockchain definitely offers some incredible perks, but it's really crucial to think things through and consider both the upsides and downsides. Just double-check that it really fits what you’re looking for before you dive in!

If you’re using centralized exchanges that have a solid grip on custodianship and don’t get tangled up in multi-party trust problems, you can totally skip the ledger. A well-managed FHIR API that comes with signed audit logs is not just easier to handle, but it also saves you money in the long run. It’s really crucial to never put any PHI on the blockchain. Even though it’s hashed, there's still a chance that someone could figure out who it is. When you’re working with off-chain storage, it's really important to prioritize security. Make sure you’re using encryption and access controls to keep everything safe. Also, remember to only store pointers or hashes for any non-PHI artifacts. This way, you’re keeping things secure while still being efficient!

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Architecture patterns that work in 2026

• Interop Backbone
• We’re noticing that FHIR R4 servers are starting to align with USCDI v3 and US Core 6, which is pretty exciting!

1. Zero is definitely having a moment right now! Meanwhile, 7. 0. So, it looks like 0 is being mapped to USCDI v4 and 8. 0. We're gearing up for version 0, which will be in sync with USCDI v5 in some of our upcoming guidelines. Oh, and let’s not forget about the SMART App Launch v2! We've got x and Bulk Data (Flat FHIR) all set up, perfect for those population use cases! Take a look at this: drummondgroup.com. It’s worth checking out!

• TEFCA alignment
• Strive for smooth connections with Facilitated FHIR and QHIN. Check out the RCE’s FHIR roadmap and Common Agreement v2! Think of SOPs as your trusty guide--they’re your main reference for everything! And hey, try to avoid sticking to just one network intermediary; it’s best to keep your options open. Feel free to take a look at it more closely at this link: rce.sequoiaproject.org. Enjoy exploring!
• Identity, Consent, and Directory.
• We're diving into VC 2 now. You’ve got flexible provider credentials with a score of 0, and when it comes to trusted directory records, you're looking at HL7 VHDir. Plus, for all your network and insurance plan details, Plan-Net has you covered. Oh, and just a quick reminder: keep those revocation lists off-chain! But make sure you have your on-chain proofs ready to go when you need them. (w3.org).
• Data Protection We’ve got FIPS 140‑3 validated hardware security modules (HSMs) in place to make sure those keys stay secure. And guess what? We’re totally geared up for the upcoming crypto upgrades, especially with NIST PQC (ML-KEM/ML-DSA) on our radar. It's an exciting time for us! We’ve got everything logged into a central SIEM, sticking to the HHS CPGs, of course. Plus, we’ve made it a priority to keep our validator nodes separate from the clinical networks to ensure everything runs smoothly. (techcommunity.microsoft.com).
• Ledger Choices Hey there! If you’re on the hunt for a reliable solution for permissioned, high-throughput workflows--think chargebacks--then you should definitely take a look at Hyperledger Fabric. It's a great option! If you're looking for EVM compatibility or want to dive into smart contract ecosystems, Hyperledger Besu or Quorum might just be right up your alley. Just remember to build a solid off-chain data layer and a good message bus. You can think of it like using FHIR Subscriptions or Bulk Data jobs along with event streaming. This way, you can keep your business payloads separate from the blockchain, which is super important! If you want to learn more about it, just check this out: build.fhir.org. Happy exploring!

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Three practical designs with implementation details

1) Provider Credentialing + Directory Accuracy at Scale

Goals

We're looking to reduce claim rejections and avoid losing money because of outdated provider information. We're also working to make the onboarding process faster and ensure that the patient-facing directories on Plan-Net are accurate and up to date.

Blueprint

We're all set to launch VC 2! You’ve got a setup where providers have their credentials, like licenses and affiliations, all lined up. The cool part? You’re keeping the revocation status off-chain, but there’s still a way to prove it that’s stored on-chain. We’re going to sync up a directory that meets the VHDir standards. After that, we’ll share the network and plan relationships through Plan-Net. Plus, we’ll make sure this data is easy to access for everyone involved with FHIR and TEFCA. (w3.org).

What to Build in Sprint 1-2

We’re currently diving into a few key projects. First off, we’re working on getting our VC issuance and verification processes up and running. We’re also building a VHDir ingestion pipeline that includes some smart deduplication and merging policies. On top of that, we're setting up Plan-Net endpoints, putting SMART scopes into action, and making sure we have proper on-chain audit notarization in place. It’s a busy time, but we’re excited about the progress we’re making!

KPIs

We're really pushing to cut down our provider directory outreach by more than 30%. Our goal is to get credential updates out in under 48 hours on average, tackle those pesky denials related to eligibility and address issues, and show some solid ROI from the blockchain directories we've already rolled out. (synaptichealthalliance.com).

2) Prior Authorization Transparency and Appeal Readiness

Goals

• Let’s make sure to stick to those CMS decision SLAs! It’s a good idea to set up workflows that are clear and super easy to appeal. And whenever we can, let’s definitely support that FHIR-only PA!

Blueprint

Let’s get started by rolling out the CRD/DTR/PAS IGs for intake and documentation. We need to make sure we notarize each state transition--like requests, documents, and decisions with their reasons--on a permissioned ledger. Plus, we'll keep all the details stored in FHIR. And hey, why not go ahead and auto-publish those PA metrics on a public page? Sounds like a great idea! (cms.gov).

What to Build in Sprint 1-2

Alright, so here’s the plan: we’re going to set up a Fast Healthcare Interop Gateway (FHIR R4) alongside PAS/CRD/DTR. We’ll also put together an on-chain event schema that covers the entire PA lifecycle. And don’t worry, we’ll make sure to document all the denial reasons too. Plus, we’re gearing up for those bulk exports so we can track our metrics properly. Let’s get this rolling!

KPIs

• Make sure to monitor our SLA compliance, like keeping expedited requests to 72 hours or less and standard ones to a week or under. It's also important to keep tabs on how often we overturn appeals, work on shortening our cycle time, and ensure we have clear, written reasons for any high percentage of determinations.

3) Hospital Pharmacy DSCSA Compliance and Chargeback Accuracy

• Goals
• Get on board with EPCIS-based traceability to make product verification a breeze. This way, you'll reduce those pesky chargeback problems and be well-prepared for any audits that come your way.
• Blueprint
• Pull together your EPCIS events with a VRS. Make sure to notarize any transaction or state proofs on a private network. When the tools for chargeback and contract alignment are ready, get those implemented. And don’t forget to keep an eye on the FDA’s enforcement dates that pertain to what you’re doing. It's super important to stay on top of that! (fda.gov).
• Things to Work On in Sprint 1-2. Alright, here’s the plan: First, we’ll get an EPCIS event validation system up and running, along with a solid repository to keep everything organized. Next, we need to create some workflows that will help us deal with any suspect or shady products--gotta keep things above board, right?

After that, we’ll set up VRS connectivity, so everything's linked up smoothly. Lastly, let’s dive into developing a chargeback rule engine that incorporates on-chain settlement proofs. This will really help us streamline the process and increase trust. Sounds like a solid roadmap!

• KPIs
• Keep tabs on how long it takes to verify tracks, watch the exception rate, and pay attention to the cycle times for chargeback disputes. Also, don’t forget to look for any cuts in write-offs once everything is up and running!

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The 12‑point checklist for choosing a blockchain development partner

1. Staying up to speed with regulations and old commitments.

• Can they get your scope in line with the CMS-0057-F APIs, deadlines, and recommended IGs? Don’t forget to look into their compliance with HTI-1 DSI/USCDI v3 by January 1, 2026, and find out what their plan for participating in TEFCA is like. Hey, just a quick reminder to check in about their migration plans and the exact dates for those deliverables! You can find more info here.

2) FHIR Mastery Beyond CRUD

• Get ready to jump into Bulk Data using $export! Let’s tackle SMART v2 together and really understand how it works. Get yourself up to speed with different authentication patterns, dive into token introspection, and get comfortable with capability statements and the Inferno test harnesses. You'll find it all pretty interesting! Also, make sure you’ve got a good handle on the US Core versions. As it stands, we’re currently at version 6.

1. Zero for now, but definitely stay tuned for updates on version 7! 0. 0 and 8. 0. 0. Take a look at it over at hl7.org! You won’t want to miss this!

3) TEFCA Strategy

Hey there! So, do you know which QHINs are currently involved? I'm curious about how they're gearing up to support the Facilitated FHIR and IAS SOPs according to Common Agreement v2. If you're interested, you can find more details here: sequoiaproject.org.

4) Directory and Credentialing Stack

Hey, quick question--can they actually roll out VHDir and Plan-Net? Also, are they good to go with issuing and verifying VC 2? Hey there! If you're looking for info on credentials for providers--like revocation and those privacy-preserving status lists--you can find all the details you need right here. It's worth a look!

5) Keeping Data Minimal and Handling PHI

We've got a great plan to ensure that there’s absolutely no PHI on the chain. This means you'll be using pointer hashes and making sure to hide any sensitive information.
If it’s relevant, we’ll go ahead and tag those with DS4P. Also, we've got straightforward policies in place about how long we hang onto data and what we do to wipe it clean off the chain once we're finished with it.

6) Security Program in Sync with HHS CPGs

• Show how Multi-Factor Authentication (MFA) works, keep up with patch management schedules, and highlight our vendor risk management strategies. Don’t forget about network segmentation and centralized logging! We’ll also want to run through some tabletop exercises for incident response. Everything we do should align with the “essential” and “enhanced” goals that the CPGs set out. For more info, take a look at this link: aha.org. It's got all the deets you might need!

7) Crypto and Key Management

• We're rocking FIPS 140‑3 validated HSMs, and honestly, that's pretty awesome! And hey, we've got crypto-agility working in our favor, along with a rock-solid game plan for making the switch to post-quantum cryptography (PQC). This covers using hybrid Key Encapsulation Mechanisms (KEM) in TLS, along with post-quantum signatures for things like code signing. Hey, just a quick reminder about our CMVP change management tracking! If you want to explore it more, check out the Microsoft Tech Community. There's some valuable info there that could really help!

8) Provenance and DSI Transparency

Hey there! Just a quick reminder about the AI features: it’s really important to have a good grasp of the DSI source attributes, auditability, and exportability stuff mentioned in HTI-1. Trust me, staying on top of that info will save you some headaches down the line! Steer clear of any black box solutions that might put your certification at risk. Trust me, it’s just not worth the hassle! If you want to dive deeper, you can find more info right here.

1. Experience with DSCSA (if you have any). Hey, don’t forget to look into EPCIS conformance, VRS connectivity, and the best ways to handle workflows for any suspect or questionable products. It’s super important! Just a friendly reminder to keep an eye on the deadlines for your pharmacy or wholesaler. You don’t want to miss anything important! If you're looking for more details, just click here. It’ll take you to the info you need!
2. Trusted Execution Environments (TEEs) and confidential computing (optional). So, if you're considering using TEEs for off-chain computations, take a moment to explore the attestation flows. It's also a good idea to look into how to upgrade the enclaves and have a backup plan in place. You never know when the enclave tech might become outdated or if a patch could throw a wrench in things. Better safe than sorry, right?

11) Operability SLOs

We set goals for transactions per second (TPS) and latency when it comes to notarization events. Plus, we’ve established our recovery point and time objectives, too. Hey, just a quick reminder to keep those migration playbooks in mind! Also, let’s make sure we’re tracking performance across the multi-org channels (you know, like Fabric) and the permissioned EVM. It’s important to stay on top of that!

12) References and Measurable Outcomes

Hey, could you share some case studies that showcase ROI? I'm really interested in seeing examples that highlight reductions in things like denials, chargeback write-offs, and verification times. Thanks! Don't forget to request some independent verification reports too! You might want to check out the SOC 2, ISO 27001:2022, and HITRUST v11 ones. They can really help you get a clearer picture of what’s going on. x. If you want to dive deeper into ISO standards, feel free to visit iso.org for more info!

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RFP questions you should copy‑paste

Governance and Compliance

Hey there! Could you let us know which APIs and Implementation Guides (IGs) from CMS-0057-F you’re planning to roll out for us and when we can expect them? It would be super helpful if you could provide a matrix that includes the endpoints, the versions of the IGs, and any test evidence you have. Thanks a bunch! If you want to dive deeper into the details, just check this link out here. It should give you all the info you need!

Hey there! How do you make sure that we're on top of HTI-1’s DSI transparency requirements when it comes to the predictive models we’ll be using? Also, I’d love to know what kind of audit exports we can expect to receive. You can find all the detailed info here. Thanks!

Hey! I’m curious about your strategy for TEFCA. What’s the deal with the QHIN partners, Facilitated FHIR readiness, and IAS support? Also, can you shed some light on the onboarding process for us? If you're looking for more details, you can check this out here. Thanks!

Architecture and Security

• Don't forget to add diagrams that clearly demonstrate there’s no PHI on the blockchain. Hey there! Could you share how you handle off-chain storage? It’d also be great to get a bit of detail on how you encrypt data when it's not being used and while it's being transferred. Lastly, I'd love to know about your redaction processes, too! Thanks!

Hey there! Quick question for you: which of the HSMs in your stack have FIPS 140-3 validation? Also, do you have a timeline for when you plan to make the switch to post-quantum cryptography (PQC) for TLS and code-signing? If you need more details, you can check out this link here. Thanks!

Hey, it would be awesome if you could align your controls with the HHS CPGs, both the essential and enhanced ones. Also, if you could share the insights from your latest tabletop incident response sessions, that'd be super helpful! For more info, take a look at this site. You'll find all the details you need there!

Interoperability and Identity

Hey! Just curious, which versions of US Core are you supporting right now? Also, what's your strategy for getting certified to align with USCDI v3? And, by the way, do you have Bulk Data and SMART app launch features in place? Hey, if you want to dive deeper into this topic, just click on this link: drummondgroup.com. It’s got all the juicy details you might be looking for!

Can you go ahead and issue and verify VC 2? Hey there! Just checking in--do you have any credentials for providers? And by the way, are you working on any integrations with VHDir or Plan-Net? If you want to dive deeper into it, you can check this out: w3.org.

Operations and Outcomes

Okay, let’s break down the Service Level Objectives (SLOs) we’re looking at here. First off, we want to focus on the latency for ledger notarization. Next up, we need to consider the total time it takes to complete the entire end-to-end Process Automation (PA) cycle. Lastly, we’ll touch on the turnaround time for verifying compliance with the Drug Supply Chain Security Act (DSCSA).
Hey, just a quick reminder to make sure you grab those quarterly KPI reporting templates!

• Can you provide two real-life examples that really show the tangible financial or operational impact?

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Implementation pitfalls (and how to avoid them)

• The “Blockchain as a database” mistake.
• Simply notarize only what’s absolutely necessary for the state transitions or proofs. If you're dealing with clinical and claims data, it's a smart move to keep it in FHIR systems that have strong access controls. This way, you can ensure that only the right people have access to sensitive information.
• There's a bit of a gap when it comes to keeping up with the latest standards. When you're kicking off a project, it’s a good idea to nail down the IG versions you’ll be using. Also, don't forget to carve out some time for any little tweaks or bigger upgrades that might pop up later on! Make sure to check out the CMS and ONC bulletins regularly for any updates or changes regarding enforcement discretion. It’s a good idea to stay in the loop! Take a look at this link: (healthit.gov). You'll find some useful info there!
• Watch out for privacy pitfalls in web and mobile apps! Hey there! Just a quick reminder: when you're working on any patient-facing interfaces, don’t forget to double-check your tracking pixels, SDKs, and CDPs. It's super important to align them with the OCR guidance and HBNR. Just a little extra diligence can go a long way! Hey, it’s definitely smart to go with server-side tagging and make sure you’ve got strong contractual DPAs set up with your vendors. It really helps to keep everything secure and running smoothly! (hhs.gov).
• Crypto technical debt Let’s make sure we pay attention to those crypto-agility interfaces. It’s important that we kick off a few PQC pilot tests to see how they perform. Also, don't forget to keep tabs on our FIPS 140-3 module inventories. Honestly, putting in the effort to future-proof things now is way better than rushing to make fixes in 2027 or 2028. Trust me on this one! Take a look at the details right here: csrc.nist.gov. It's got all the info you need!

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Emerging best practices to bake in now

• Get Excited for TEFCA's Easy FHIR! So, whether you’re diving right into a QHIN or taking your time, just make sure your FHIR security setup and directory endpoints are ready to mesh well with TEFCA processes. Trust me, you don’t want to have to completely revamp everything down the line! (rce.sequoiaproject.org).
• Think of DSI transparency as a crucial element in your design journey. Right from the start, make sure to keep a clear record of the model's background, the features you're using, any possible hiccups, and how it's performing. Keep it simple and easy to understand! Don’t forget to create feedback loops so we can share this information and keep up with regular quality and safety checks. It’s super important to stay on top of things! (himss.org).
• Using HHS CPGs as Guidelines for Acceptance. Make sure to consider things like MFA, email security measures, centralized logging, vendor incident reporting, and system segmentation as essentials. These are really important! Just a quick reminder to keep your node and CI/CD security aligned with the CPGs. It’s super important to make sure everything matches up! If you want to dive deeper into the details, feel free to take a look here. Happy exploring!
• Making sure contracts are ready for PQC. When you're drafting your maintenance agreements, don't forget to add clauses that ensure there's support for hybrid key exchanges and any upgrades needed for PQ-ready modules. It's a smart move to cover all bases! Just a quick reminder to make sure you’re pushing for a timeline that aligns with the NIST FIPS and CMVP guidelines. It's super important! (nist.gov).

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Bottom line

When picking a partner, go for someone who really values FHIR and security instead of just hopping on the whole "blockchain" trend. It’s important to choose wisely! Just make sure they can show that they’re following the rules for CMS‑0057‑F, HTI‑1, TEFCA, HHS CPGs, and FTC HBNR. It’s really important to have that proof in place! We really need to focus on getting strong deliverables, like VC 2. It's key! You're all set with zero credentials needed! We’ve got the VHDir/Plan-Net integration, FIPS 140-3 HSMs, plus on-chain notarization to ensure that your PHI stays super secure. When you approach it the right way, distributed ledgers can really boost the transparency, auditability, and resilience of workflows like prior authorization, credentialing, and DSCSA. Plus, they can do all of this without adding any extra risk or costs to the mix.

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Summary (description)

A Practical Buyer’s Guide for Healthcare Leaders

When healthcare leaders are diving into blockchain solutions, it’s super important for them to consider the current landscape in the U.S. Let’s talk about interoperability, privacy, and cybersecurity rules. These are pretty important topics that affect how different systems communicate, how we protect personal information, and the overall safety of our online activities. These rules aren’t just some boring red tape--they're actually super important for coming up with great solutions. Here’s a handy 12-point checklist, plus a few questions you might want to ask in your RFP. These should really help you narrow down your search for the perfect development partner! We've added some info on TEFCA, HTI-1, CMS prior authorization, HHS CPGs, DSCSA, and PQC readiness too.

Key Considerations for Blockchain Solutions

• Interoperability: Be sure to get your solution in sync with the latest standards. This will help things flow smoothly when it comes to sharing data.
• Privacy: It's super important to keep patient data safe, so make sure to follow HIPAA and all the other privacy rules out there.
• Cybersecurity: Make sure to put solid security measures in place to protect your sensitive info from any breaches.

12-Point Checklist for Selecting a Development Partner

1. Experience with Healthcare Blockchain. Try to find partners who have a strong track record in healthcare blockchain projects.

2. Understanding of Regulatory Compliance. They really need to have a solid grasp of TEFCA, HTI-1, and all those CMS regulations. Understanding the details is key!

1. Strong Security Practices
   Make sure to see if they really focus on cybersecurity and privacy in what they offer.
2. Flexible Architecture
   Make sure their technology is flexible enough to keep up with future interoperability standards.
3. Proven Track Record
   Don't hesitate to reach out and ask for some case studies or references from past clients. It’s a great way to get a feel for their work and see how they've helped others in the past!
4. Technical Expertise
   They really ought to have a talented team that knows their way around blockchain development.
5. User-Friendly Design
   Healthcare providers need solutions that are simple and straightforward to use.
6. Integration Capabilities
   Try to find solutions that easily fit in with the systems you already have in place.
7. Scalability
   It's important that your partner's solution can evolve alongside your organization as it grows.
8. Support and Maintenance
   They really should provide some ongoing support after everything's up and running.
9. Transparent Communication
   Keeping the lines of communication open is super important during the entire development process.
10. Custom Solutions
    They should be ready to customize their services to fit what you really need.

RFP Questions to Consider

So, how do you make sure you're following the TEFCA and CMS regulations? So, what steps do you guys take to keep patient privacy and data security in check? Sure! I'd be happy to share some examples of successful healthcare blockchain solutions we've worked on.

• So, how do you go about integrating new systems with the healthcare tech that's already in place? So, what kind of support do you provide once the solution is up and running?

If you keep these points in mind and ask the right questions, you'll be in a much better position to find a development partner who really fits what you're looking for. If you want to dive deeper into the important regulations, take a look at the CMS Interoperability and Prior Authorization Final Rule. It’s a great resource to get all the info you need!