Section 23 of the Assisted Reproductive Technology (Regulation) Act, 2021 tells an ART clinic to keep detailed records of every donor oocyte, sperm sample and embryo, used or unused, with the manner and technique of their use, to hold them at least ten years, then transfer them to the central database of the National Registry. If the clinic closes earlier, the records move immediately. If proceedings are brought, they are preserved until those proceedings end.
That is a software specification written into a statute, and it is why a general clinic system cannot run an IVF unit. The Act, in force since 25 January 2022 along with the Surrogacy (Regulation) Act, 2021, sets out what is recorded, who may see it, what is reported and for how long. Buying IVF software is mostly checking a product against those obligations.
Registration comes before software
Under section 15, no clinic or bank may be established or offer ART procedures unless registered, and applications go to the National Registry through the State or Union territory's appropriate authority. Registration under section 16 runs five years, renewable for five more under section 17. The National Assisted Reproductive Technology and Surrogacy Registry, set up under section 9, is the central database and runs as an online portal with clinic and bank logins.
Be clear about the boundary, because vendors blur it. Filings happen on the government portal, by your staff, under your registration. Software can hold the fields in the shape the Registry asks for, so a submission is an export and a check, not a fortnight of copying from case sheets. A product that claims to file for you is describing something it does not do.
The cycle is the record
A cycle is not a visit. It starts with a protocol and a baseline scan, and runs through day-by-day stimulation with drug and dose, monitoring scans with follicle measurements and endometrial thickness, hormone values from the lab, a timed trigger, retrieval, fertilisation, culture, transfer or freeze, luteal support, a beta hCG, and an outcome that may be months later.
Ask in the demo for a single cycle sheet holding all of it in one view, day numbers computed, and two of a patient's cycles side by side. Ask what happens when a cycle is cancelled after stimulation and before retrieval, since that is where weak systems leave an orphan record that never reaches the outcome report.
Section 24 gives you three checks the software should enforce instead of leaving to memory. Not more than three oocytes or embryos may be placed in the uterus during a treatment cycle. A woman is not treated with gametes or embryos derived from more than one man or woman in any one cycle. Semen from two individuals is never mixed. Ask the vendor to record a transfer of four embryos and watch what happens.
Embryology and witnessing
The laboratory side is where general clinic software offers nothing. Every movement of a gamete or an embryo, from dish to incubator to straw, needs an identity check by a second person, recorded with both names and a timestamp, in a trail nobody can quietly edit later. On paper, by witnessing hardware or in the software, that record has to exist and be retrievable years later.
Ask to see the audit trail as an assessor would: pick one embryo and follow it from insemination through each grading observation to transfer or freeze, showing who performed and who witnessed each step. Ask how a wrong entry is corrected, since the original has to stay visible, and what happens when the same surname appears twice in one morning's list.
Consent as versioned documents
Section 22 requires written informed consent of all parties before any procedure, and insurance cover for the oocyte donor for twelve months. Cryopreservation needs specific written instructions and consent covering the death or incapacity of any party. Either of the commissioning couple may withdraw consent at any time before transfer to the uterus.
So consent is a versioned object attached to a named party and a named procedure, with the signed copy stored, the date recorded, and a withdrawal timestamped and visible on the cycle screen before a transfer is booked. A folder of scanned PDFs is not this. Ask to see the system refuse, or at least flag, a booked transfer where consent is missing or withdrawn.
Section 21(e) keeps information about the commissioning couple, the woman and the donor confidential, disclosed to nobody except the National Registry database, in a medical emergency at the request of the couple it relates to, or by court order. In software that is roles separating the front desk, the clinical team and the laboratory, plus a log of who opened which record and when.
Storage and outcomes
Storage records have to identify the physical location, in practice tank, canister, cane and position, with the number of straws, the freeze date and the consent covering them. Ask how a partial thaw is handled, and for the report you would hand an inspector listing everything in storage with the consent behind each entry.
Outcome reporting is a statutory duty, not a management dashboard. Section 21(j) requires clinics and banks to give the National Registry, periodically and in the prescribed manner, information on enrolment of the commissioning couple, woman and gamete donors, the procedure undertaken, and its outcome with any complications. Section 23(b) adds online submission of progress information and donor numbers within one month, and section 21(h) a discharge certificate stating details of the procedure. Each is a field, a form or an export you can ask to see.
Retention deserves a last look. Ten years under section 23(c) for ART records, and for a clinic that also does surrogacy, twenty-five years under section 46 of the Surrogacy (Regulation) Act, 2021 for records, consent letters and agreements. Ask any vendor what happens to your data if you stop paying, and get it in the contract.
ExaHealth's place in an ART clinic
ExaHealth is general clinic software. It has no embryology module, no witnessing trail, no cycle sheet and no Registry export, so it has no part in the ART record-keeping the Act describes. Where a clinic runs an outpatient side alongside the ART unit, it covers the ordinary part: an appointments calendar and a live queue, patient files that open with history and documents loaded, e-prescriptions and reports sent on WhatsApp with no app, one-tap invoices showing pending payments, and role-based access with an audit trail of who opened a record and when, on data hosted in India. It is an ABDM-certified PHR and health locker, so with consent a patient's ABHA links to receive and share records. For the cycle, the laboratory and the Registry, buy an ART system.
The order to work in
Read sections 21 to 24 yourself before any demo, then make each vendor work through them in that order. It is a dull afternoon, and it separates products built for ART from clinic systems that added a page called "IVF". On which category of product a facility needs, see hospital management software compared with clinic software; on the national record-sharing layer, our ABDM checklist.
If it is the outpatient side of an ART practice you are equipping, the ExaHealth page for doctors lists what it does.
Sources
Assisted Reproductive Technology (Regulation) Act, 2021 (No. 42 of 2021), assented 18…
Both the ART Act and the Surrogacy Act came into force on 25 January 2022
Surrogacy (Regulation) Act, 2021, section 46(1): records, charts, forms, reports, consent…
The National ART and Surrogacy Registry operates as an online portal with clinic and bank…