Blockchain Development Services for Healthcare: A Procurement Guide for Hospitals and Insurers

Summary: This guide is your go-to for figuring out how to pick and implement blockchain solutions that really boost accuracy in provider data, make prior authorizations easier, and keep everything in line with regulations in the drug supply chain. We’ve made sure this guide is in sync with what's coming up in the U.S. So, when we’re talking about regulatory timelines for 2025 to 2027, we really need to dive into a few key areas. First off, there’s the whole deal with FHIR and TEFCA, which can feel a bit overwhelming. Not to mention, we can’t forget about the security measures that hospitals and payers have to implement to keep everything safe and sound. It's a lot to think about, but it's super important for making sure we’re all on the same page moving forward.

Why blockchain now: three market signals decision‑makers can’t ignore

TEFCA is officially in action, and it's gaining momentum! By January 16, 2025, we saw eight QHINs officially get their designation. These include familiar names like eClinicalWorks, CommonWell, eHealth Exchange, Epic Nexus, Health Gorilla, Kno2, KONZA, and MedAllies. Exciting times in the health tech world! By the end of 2024, more than 9 million documents had already been shared through TEFCA, and things are really starting to heat up! Given all this, making sure we can trust cross-network exchanges and accurately track where documents come from is more crucial than ever. Take a look for more info! You can find all the details at sequoiaproject.org.

The CMS's Interoperability & Prior Authorization Final Rule (CMS‑0057‑F) is really focused on making those admin processes quicker and more efficient. Hey there, payers! Just a heads-up--make sure to save the date! Starting January 1, 2026, you're going to need to stick to those operational prior authorization decision timeframes. Don’t forget! Oh, and just a heads up: by January 1, 2027, you're going to need to have those FHIR-based APIs for Patient, Provider, Payer-to-Payer, and Prior Authorization all set up. Plus, you’ll be expected to start sharing your metrics with the public. So, it's a good idea to get ready for that! Just a heads up--HHS is taking it a little easier on enforcement right now. So, while you're getting things rolling with the FHIR-only PA APIs, you won’t have to worry about any penalties for not using the X12 278. If you want to dive deeper into it, feel free to check it out here. It’s got all the details you need!

The DSCSA package-level traceability is really picking up steam now, and it’s rolling out in phases that are based on different roles. Alright, so here’s the scoop: the FDA's post-stabilization exemptions are set to stick around until 2025 for manufacturers, repackagers, and distributors. So, for the big dispensers, the deadline is set for November 27, 2025. The smaller ones, on the other hand, get a little extra breathing room--they're due by November 27, 2026. So, what this really means is that getting your drug tracing system to be both interoperable and auditable isn’t just a bonus--it’s something you absolutely need to have figured out by around 2025 to 2026. Take a look at this link: fda.gov. It’s got some good info you might find helpful!

All these updates really show off how useful tools that can track data lineage are. They make it super easy to build trust between different organizations and create audit-ready trails. Honestly, these are exactly the kinds of areas where permissioned blockchain can really stand out and make a difference.

Buy for outcomes, not hype: three high‑ROI healthcare use cases

1) Provider data accuracy and credentialing

Regulations: With the new No Surprises Act in place, commercial plans have to update their provider directories every three months. This means they’re now checking those listings more frequently to keep everything accurate. They should also make sure to update any changes within two business days and get back to member questions in just one business day. These rules really show how frustrating it can be when information is old or gets updated inconsistently. (dfs.ny.gov).

Here's the deal: Even with the NSA around, studies show that there have been ongoing inaccuracies in a lot of listings for more than 540 days now. This really emphasizes that having good governance and keeping things updated is just as important as the technology we use. (ajmc.com).

What works: A collaborative, permissioned ledger that:
It keeps an eye on all the signed attestations whenever there are changes in provider data. Plus, it saves hashes of any credential documents. Meanwhile, the FHIR-mapped payloads are stored off-chain in your PDM/MDM.
Distributes W3C Verifiable Credentials (VC 2). You can easily verify a practitioner's identity and their privileges without having to sift through old documents. Verifiers have the convenience of checking proofs directly, making the whole process a lot simpler. (w3.org).
It provides your TEFCA/QHIN directory services and payer portals with info pulled from one trusted source.
Just a quick note: The Synaptic Health Alliance has some really cool stats on multi-payer ROI that you should check out! One of the team members mentioned that they’ve managed to score an incredible 500% annual return on investment from a project they worked on for a provider directory. They hit this big milestone by going through and validating millions of public records using a shared ledger. (synaptichealthalliance.com).

What to Include in an RFP

We've got VC/DID support that matches up with the W3C DID Core 1. Zero for those issuer, holder, and verifier processes. Basically, this means we need to find DID methods that let us rotate and revoke options. If you want to dive deeper into this topic, just click here for all the details!

You’ve got a 2-day turnaround for getting those verified changes into the directories that need them. Plus, you can export details for each change, including its origin and some cryptographic proof to back it up.

2) Prior authorization you can audit end‑to‑end

Regulations: Hey there! So, CMS-0057-F is really changing the game with its fresh rules regarding FHIR APIs and transparency. These days, if you're making an expedited request for prior authorization (PA), they’ve got to make a decision within 72 hours. For the standard requests, you’ll typically wait about a week, or 7 days. So, starting March 31, 2026, we can expect to see some public metrics rolling out for everyone to track. Then, by 2027, there will be a straightforward yes/no attestation for electronic prior authorizations. Pretty straightforward, right? On top of that, the HIPAA Administrative Simplification enforcement discretion is really smoothing the way for rolling out FHIR-only PA API implementations. It's making things a lot simpler and more straightforward! If you want to dive deeper into the details, you can check it out here. Enjoy!
Here are some standards you should watch out for:
HL7 Da Vinci PAS (right now, it's at version 2).

1. 0; v2. 2. You're currently in the ballot phase for Prior Authorization transactions, which includes **CRD (v2).

1. 0)** and **DTR (v2.

1. 0)** to assist you in capturing payer rules and documentation in a format that's easy for computers to understand. Check it out here.

ONC HTI‑1 baseline: Just a heads up, you should look out for USCDI v3 rolling out by January 1, 2026. Also, don’t forget that SMART App Launch v2 needs to be set up and ready to go by December 31, 2025. These updates are going to affect API security and the way we register apps. If you’re looking for more info, you can check it out here. There’s a bunch of details waiting for you! Starting on October 1, 2025, the ONC HTI-4 will roll out some fresh certified criteria focusing on things like e-prescribing, RTPB (real-time pharmacy benefit), and ePA (electronic prior authorization). It's an exciting step forward! These factors are definitely going to play a big role in how your solution connects with EHRs and payers. So, it’s definitely worth taking the time to think this through and plan accordingly. If you want to dive deeper into it, check this out here!
Why blockchain:
So, when you use blockchain, you get these cool time-stamped state changes for CRD to DTR to PAS events that can't be altered. It really helps keep everything on the up and up! This helps us get a clear picture of performance metrics like cycle time, rework, and reasons for denials, all while making sure we keep any personal health information (PHI) secure and off the chain. At the end of the day, it really comes down to having robust audits that you can stand behind. So, when it's about keeping rules up to date across different organizations, any changes to payer policies are handled as signed documents that we can track by version. We keep the hashes stored on-chain, but the info from CQL and the Questionnaire just chill off-chain. This way, providers can easily show which rules played a role in making a decision on a specific date.

Practical requirement:

Link every PA request and response together by using a unique ID to create a chain of events. Just a quick reminder: make sure to add those denial reason codes that CMS needs in the off-chain FHIR bundle that you link from the ledger entry. It’s super important! If you want to dig deeper into the details, just head over to cms.gov. There's a ton of good info waiting for you there!

3) DSCSA package‑level traceability and exceptions handling

What’s Coming Up for 2025-2026: So, it looks like the FDA is planning to introduce some exemptions that will actually delay enforcement past the stabilization period in 2024. So, here’s the scoop on the timeline: distributors can take it easy until August 27, 2025. Large dispensers are off the hook until November 27, 2025, and for the small dispensers, they’ve got a bit more time, with a deadline of November 27, 2026. It's really important that we have smooth traceability, verification, and exception management with all our trading partners. If you're interested in diving deeper into this topic, you can check it out here.
A solid example: The MediLedger FDA pilot, which brought together 25 top pharma companies, really showed off how blockchain can make the process of transferring ownership both secure and seamless. This really shook things up for a lot of manufacturers and wholesalers as they rolled out their DSCSA-ready designs. (mediledger.com).
What to buy: So, we’ve got this permissioned network that really supports EPCIS/GS1 events. It’s super helpful for verifying products and also takes care of any disputes using smart contracts. Hey! Just a quick reminder to make sure you integrate with your serialization repository and VRS. Don't let that slip your mind! So, we’ve got the evidence package exports all set up, which include those hash chains and signatures that auditors actually find acceptable. This is super helpful when it comes to handling exceptions, you know, like those annoying serial mismatches or those tricky returns we can’t really verify.

A reference architecture that passes real‑world scrutiny

Permissioned DLT core: If you're diving into healthcare consortia, you might want to check out networks built on Hyperledger Fabric or Besu. They could be a great fit! These options have really taken off! People love them because they let you manage private data collections and channels easily. Plus, they provide Byzantine-fault-tolerant finality, which is super reliable. You can even set them up right on-site or in cloud environments that meet HIPAA standards.
On‑chain vs. off‑chain:
On-chain: In this section, you’ll discover references that are content-addressed, along with cryptographic commitments such as SHA-256 hashes linked to FHIR bundles. You’ll also come across signed attestations, event/state indices, and consent receipts.
Off-chain: This is basically where all your sensitive health info and bigger files hang out, like FHIR Resources or PDFs. You can find them in your electronic health record (EHR), your insurance platform, or tucked away securely in an encrypted data lake. You can check them out using auditable APIs.
Identity and credentials: Hey, have you considered using W3C DID/VCs for your practitioners, facilities, and organizations? It could really streamline things! With this approach, you can easily issue, share, and revoke credentials without needing to gather all those original documents in one spot. Take a look at this link: w3.org. You might find it really interesting!
To improve patient matching, let’s align it with the Project US@ address standard. This is going to make it way easier to connect FHIR resources when they’re shared through APIs and TEFCA. If you want to dig deeper into the details, check this out: (govinfo.gov). It’s got all the info you need!
Interop edges: Make sure to keep an eye on FHIR R4 US Core versions 6. It’s definitely worth your attention! 1/7. So, we've got a few things on our plate: SMART v2, Bulk Data, and Da Vinci IGs. Oh, and remember to keep TEFCA endpoints in mind, along with QHIN connectivity when it comes to clinical data and directory services! Hey, take a look at this for more details: (himss.org). You'll find some pretty interesting info there!

Security, privacy, and compliance checklists your vendor must pass

Sure thing! Let’s break down the main points about the HIPAA Security Rule. Here’s the scoop:

Audit Controls: It's important to be able to “track and review” any actions happening on systems that deal with electronic Protected Health Information (ePHI). This means keeping a close eye on everything going on to ensure everything’s above board. Basically, this involves linking up event chains and API logs to section 164. 312(b). Check it out here.
Encryption "safe harbor": If you want to dodge those pesky breach notifications for lost media, just remember to encrypt your ePHI following the guidelines from HHS and the NIST Special Publications. It’s a smart move that can save you a lot of headaches! Just a quick reminder: make sure to keep your encryption keys and ciphertext apart. It’s an important practice! More on that here.
Ransomware situation: If ePHI was exposed in plain text during an attack, you should consider it a breach. Oh, and don’t forget to set up some solid audit trails that you can’t mess with. They really come in handy when you’re working on those risk assessments! If you’re interested in diving deeper into that topic, feel free to check it out here. It's got some great info!
Crypto Modules and Getting Ready for Post-Quantum: Hey, just a heads-up! It's super important to use FIPS 140-3 validated crypto modules, or at least have a solid plan documented if you're not. Don't forget to jot down the certificate numbers as well! Hey there! Just wanted to give you a quick heads up. FIPS 140-2 is still good for your current systems, but starting September 22, 2026, it’ll be moved to the “historical list” for any new validations. So, keep that in mind for future updates! If you want to dive deeper, you can find more info here.

Hey there! It’s time to get a move on with your PQC (Post-Quantum Cryptography) migration! NIST is gearing up to roll out the standard for ML-KEM, ML-DSA, and SLH-DSA (FIPS 203-205) next year, in 2024. So, why not start planning now? Oh, and by the way, HQC was approved as a backup KEM back in March 2025! Talking to your vendors about a hybrid-crypto plan is definitely a smart move. You'll want to check in and see if their timelines match up with the NIST IR 8547 transition guidance. It helps keep everything on track! If you want to dive deeper into this topic, check out more information here. It's a great resource!

Patient Rights vs. Immutability: Sure thing! So, let's talk about the right to amend under HIPAA (that’s the Health Insurance Portability and Accountability Act, if you weren’t aware). It’s all about giving you the power to request changes to your health information. According to section 45 CFR 164, you have the right to ask for corrections if you think something’s not quite right. It’s important for making sure your records are accurate and reflect your true health situation. So, if you ever feel like something’s off, don’t hesitate to speak up and set the record straight! You can do this by adding correction records and linking them back to the original entries. Blockchain should really keep a record of all the changes that happen, instead of just locking in incorrect information. It's all about transparency, right? (law.cornell.edu).
Data-sharing policy alignment: Hey there! Just a heads-up: the ONC HTI-1 DSI/AI transparency is going to affect the certified tools you’re thinking about using. When you're working with AI-assisted rules in DTR or Davinci flows, it's super important to clearly indicate where those source attributes come from and what risk controls are in place. This way, everyone’s on the same page and knows the ins and outs of the processes! (healthit.gov).

Procurement criteria: what to put in your RFP

Reach out to the vendors and ask them to send back some proof about the following:

1) Regulatory alignment and timelines

We're working hard to provide complete support for the CMS‑0057‑F APIs and metrics, and we have a solid plan in place for delivery. We're aiming to get our APIs up and running by January 1, 2027. Plus, we want to have our operational metrics sorted out by either January 1 or March 31, 2026. We've got a timeline, and we're excited to stick to it! This will connect back to our mapping for the Da Vinci PAS, CRD, and DTR. Hey, take a look at this CMS fact sheet! It’s got some interesting info worth checking out!

Alright, let’s chat about how our solution is going to handle TEFCA connectivity. We’ll look at the way it manages the exchange and anchoring of provenance for documents that come from the designated QHINs. If you want to explore this topic a bit more, check out the Sequoia Project's website. They have some great info that can really help! Just head over to this link to dive in!

Alright, so when it comes to DSCSA, we really need to show how all the chain events fit together smoothly with EPCIS repositories and VRS flows. This is super important, especially regarding those verification exceptions at distributor and dispensing points, especially with the enforcement schedule coming up in 2025-2026. Check out the details over at the FDA! You’ll find all the info you need there.

2) Architecture and Data Handling

We’ve got a pretty good balance between on-chain and off-chain data, and we're all about keeping it simple. We don’t store any personal health information (PHI) on the blockchain. Plus, if we do manage any PHI, it’s encrypted both when it’s stored and while it’s being sent around, sticking to the guidelines set by HHS and NIST. On top of that, we've got our key custody model all set up. It covers a bunch of important stuff, like Hardware Security Modules (HSM), Bring Your Own Key (BYOK), and even practices for rotating keys. So, we’re really thorough in making sure everything’s secure! If you’re looking for more info, take a look at the HHS guidance. It's got a lot of helpful insights!

We've got all the proof we need to show we're in line with different standards. We've got some test reports that confirm we're all set when it comes to meeting the requirements for FHIR R4 US Core, SMART v2, Bulk Data, and the Da Vinci IGs we talked about earlier. If you're interested in diving deeper into this topic, check out HIMSS. They've got some great resources!

3) Identity, Credentials, and Access

Let’s jump into the W3C DID/VC 2! You've got zero flows that handle everything from provider credentialing to updating directories, managing revocation lists, tracking status lists, and of course, those crucial audit proofs. Hey there! If you're interested, you can find all the details about the Verifiable Credentials 2.0 specifications being recognized as a W3C recommendation by clicking here. It’s worth checking out!

Security Attestations

We have FIPS 140‑3 module validation IDs, plus we're all set with SOC 2 Type II and HITRUST for our hosting services. Also, just so you know, our PQC roadmap aligns really well with the NIST guidelines. Take a look at this link: (csrc.nist.gov). It's worth checking out!

5) Operational Excellence

We’ve put together some solid SRE practices, and we’ve got well-defined RTO and RPO targets to guide us. Plus, we regularly run disaster-recovery tests to keep things sharp. On top of that, our node and API observability is looking great! Also, we've got solid evidence that our audit logs are tamper-evident and in line with §164. 312(b). Feel free to take a look at the specifics over at this link: law.cornell.edu. It’s got all the info you need!

6) Exit Strategy

Data Portability: It's super important to be able to easily export all your on-chain commitments, off-chain artifacts, and Merkle proofs in formats that are widely recognized. This way, you won’t run into any hiccups when you need to access your data! On top of that, we’ll set up a read-only node escrow to give you some extra peace of mind.

KPIs and SLAs that predict real value

Keeping Provider Directory Accurate (NSA): We're aiming to update you within 2 business days, and we're shooting for under that if we can! Let’s aim to keep duplicate entries down to about 5% and make sure our bounce rates for outreach stay below 2%. On top of that, we’ll have clear evidence of all our verification efforts. We’re all about finding ways to save money, and one of our main targets is to cut down on those manual directory interactions by about 20-30% from where you’re currently at. The CAQH data really shines a light on how much administrative waste we're dealing with and shows us the big savings we could snag by automating verification and prior authorization. Take a look at this: (caqh.org). It's worth exploring!
Prior authorization:
Cycle times: On average, it takes less than 48 hours to make a decision on standard requests, and for those expedited requests in our pilot programs, we're looking at a cool under 12 hours! And you know what? Every time a request comes in, there’s a 100% guarantee that a denial reason will be given, all thanks to those CMS requirements. Since we adopted the CRD/DTR, we're seeing a resubmission rate of under 10%! That's pretty encouraging, right? (cms.gov).
Transparency: Have you seen it? There are almost real-time dashboards that give you access to all the important CMS PA metrics. And the best part? It's all out there for public reporting! Plus, you can dive into the details and check out the cryptographic proof for every single transaction. It's pretty cool to see how everything's verified! (cms.gov).
DSCSA:
We're actually hitting those target response times for verification on both the distributor and dispenser sides, which is great news! We're keeping an eye on how long it takes to sort out any exceptions, and we’ve got all the signed dispute trails to back it up. On top of that, we're really focusing on making sure we're hitting all the FDA's requirements for data connections that work seamlessly together. (fda.gov).
Security: We're really excited to share that we offer a fantastic 99! We're rocking a 95% API uptime, and the best part? We haven't had any critical CVEs lingering for more than 30 days. We're currently using our FIPS-validated modules, and we’ve successfully completed the PQC hybrid testing right on schedule, making sure it fits perfectly with your risk profile. Take a look at this link: (csrc.nist.gov). It’s worth checking out!

Implementation playbook (aligned to 2025-2027 milestones)

0-60 days: Checking Compliance Gaps and Choosing Use Cases.
Check out the NSA directory workflows and PA endpoints closely. Take some time to assess how prepared each partner is for DSCSA. Hey, can you take a moment to double-check the TEFCA/QHIN participation routes? Also, let’s map out the dependencies for HTI-1 and HTI-4. Thanks! (rce.sequoiaproject.org).
60-150 days: Kicking Off the Pilot Build.
Create a permissioned network in a HIPAA-compliant cloud environment. Alright, so here's the plan: we'll issue DID/VC for one group of providers. Next, we’ll link up the CRD/DTR/PAS with a single payer. And just a heads-up, let’s make sure we keep things safe by anchoring events on-chain but avoiding any PHI getting stored there. Sound good?
Go ahead and set up PA metrics using the CMS templates, and make sure to enhance the audit controls in line with §164. 312(b). (cms.gov).
5-9 months: Get Ready for Production. Let’s get more payers and provider groups on board! It’s time to start those updates for directories and credentialing. Let’s kick off a public process for sharing PA metrics! Hey, just a quick reminder to check the evidence for the FIPS module and finish up the PQC migration plan. Thanks! (cms.gov).
2026-2027: Keeping Things in Check and Fine-Tuning. Hey there! Just a reminder to keep an eye on those CMS 2026 metrics and stick to the operational rules. And don’t forget about the 2027 API deadlines -- they’ll be here before you know it! It really comes down to consistently making those denial reasons better, resubmitting things, and boosting our overall efficiency. Hey there! If you're working in the pharma and dispensing side of things, it's time to say goodbye to those DSCSA exemptions. Let's gear up and showcase full package-level interoperability with all your trading partners by your deadline. You've got this! For more details, you can take a look right here: (cms.gov).

Pitfalls to avoid

**Putting PHI on-chain. This is going to complicate things a bit when we’re dealing with breach responses and figuring out the right to make changes. It’s a good idea to keep personal health information (PHI) off the blockchain and just use hashes for referencing it. This way, you’re protecting sensitive data while still being able to track and verify things when you need to. If you want to dive deeper into the specifics, just click here for more info!
**Ignoring X12/FHIR interplay. Just a heads up--if you’re focusing only on FHIR, don’t forget that there are still a bunch of edge systems involved. Pick vendors who can actually connect the dots when it comes to standards, rather than just going through the motions with FHIR. If you want to dive deeper into this topic, check out the info over at CMS. It's a great resource!
**Overlooking address standardization. If you don’t get your addresses sorted out, you’re going to face some serious problems when it comes to matching patients. And trust me, that can really mess with how effective your ledger is! Don't forget to roll out Project US@ normalization at your FHIR boundaries! It's super important to get that right. If you want to dive deeper into it, check it out here.
**Not bothering with crypto validation and PQC planning. Hey, don't put off asking for those FIPS 140-3 certificates and a good PQC roadmap. Seriously, tackling this stuff down the line can end up costing you a lot more in the long run. So, it's best to get it squared away now! For all the specifics, check out the details over at NIST. They’ve got everything you need to know!

What “great” looks like in 2025

We've got this awesome provider directory backed by a ledger that ticks all the right boxes for NSA verification timelines. It provides cryptographic proof for every single change, which is super helpful. Plus, it makes it way easier to connect with providers--no more jumping through hoops! It really resembles the multi-payer ROI we’re already seeing in the production consortiums, which is pretty exciting. (dfs.ny.gov). Picture this: you've got an ePA pipeline that's super easy to audit. It's designed so that the CRD flags all the essentials, while the DTR collects just the info we need. Then, PAS handles sending everything out and getting decisions back. And the best part? Every single step is connected to a specific rules version and timestamp. This setup is perfectly geared for CMS transparency reporting, making the whole process a breeze! (hl7.org). We've got a solid DSCSA framework that really helps keep everything organized when it comes to serializations and exceptions between partners. It includes on-chain proofs and off-chain payloads, making sure everything stays on track with the FDA’s phased enforcement timeline. (fda.gov).

How 7Block Labs delivers

Advisory first: We start things off by breaking down the rules from CMS, ONC, and the FDA into straightforward acceptance criteria and easy-to-understand RFP language. Next, we go a bit deeper and figure out just how much money could be saved by using the CAQH benchmarks for administrative tasks. Take a look at this: (caqh.org). It's definitely worth your time!
Build with guardrails: We're all about laying down a strong foundation over here. Alright, picture this: you’ve got permissioned distributed ledger tech (DLT) on your side, paired with smart connections using FHIR, SMART, and Da Vinci. On top of that, toss in some decentralized identifiers (DIDs) and verifiable credentials (VCs) for keeping your credentials safe and sound. It’s like having a digital toolbox that not only helps manage secure credentials but also makes everything super efficient and reliable! Rest assured, we've got everything mapped out to align with TEFCA. Plus, you can relax knowing there's absolutely no Protected Health Information (PHI) stored on the chain.
Show and grow: We're all about making real, trackable improvements in important areas. This includes things like making sure our directory info is spot on, speeding up the prior authorization process, and tackling any DSCSA exceptions that come our way. We’ve got your back with tamper-evident logs that follow all the guidelines set out in §164. 312(b). Curious to learn more? Check out this link: law.cornell.edu. It’s a great resource that dives into the details!

Hey there! If you need a tailored procurement checklist or a 6-week feasibility sprint that’s just right for your network, we’ve got your back! Just let us know how we can assist you!