Intended Use & Clinical Safety Statement
This Statement defines what MyOPD, supplied by Caresoft Systems Private Limited, is designed to do and — equally important — what it is not. It forms part of the Terms of Use and prevails over any marketing material, proposal or verbal statement on any question of intended use or clinical safety.
MyOPD IS A RECORD-KEEPING AND WORKFLOW SYSTEM. IT DOES NOT PRACTISE MEDICINE.
It records what the treating doctor decides. It does not diagnose, does not recommend treatment, does not suggest or check doses, does not warn about drug interactions or allergies, and does not review anything the doctor enters.
Every clinical decision is the treating registered medical practitioner's, made on their own judgement and their own responsibility.
1. Intended use
MyOPD is intended for the administrative and record-keeping operation of an outpatient clinic. Specifically:
- Registering patients and maintaining demographic records
- Accepting and managing appointments, including through messaging channels the clinic configures
- Issuing and displaying consultation tokens
- Recording the consultation as entered by the treating doctor — history, examination notes, diagnosis, advice
- Recording and printing a prescription as composed by the doctor
- Recording investigations advised and results as entered
- Billing, receipts and payment records
- Management information reports on clinic activity
- Where the clinic enables it, exchanging records under ABDM using the patient's ABHA
2. Intended users
| User | Requirement |
|---|---|
| Treating doctor | A registered medical practitioner holding current registration with the National Medical Commission or a State Medical Council (or the relevant council for their system of medicine), practising within their qualification and scope |
| Front desk and clinic staff | Trained on the clinic's workflows; act only within the role the clinic assigns |
| Clinic administrator | Responsible for configuration, masters, user access and clinic-level settings |
| Patients | Where a patient-facing feature is enabled, patients interact only for booking and receiving their own information — never for clinical entry |
Prescriptions may be composed and issued only by a registered medical practitioner. Where clinic staff operate the system on a doctor's instruction, the doctor remains responsible for the content and must verify it before it is issued. The clinic must not configure workflows that allow a prescription to be finalised without the doctor's involvement.
3. What MyOPD is not for
| Not intended for | |
|---|---|
| Emergency or resuscitation use | Not designed for it |
| Inpatient care, ICU, operation theatre or ward management | Out of scope |
| Continuous physiological monitoring or alarming | Not a monitoring system |
| Diagnosis, triage or risk scoring | Does not do this |
| Dose calculation, titration or drug checking | Does not do this |
| Interpretation of investigations or images | Does not do this |
| Automated or unsupervised prescribing | Prohibited |
| Paediatric weight-based dosing calculation | Does not do this — see §5 |
| Use by anyone not qualified to practise | Prohibited |
| Sole retention of legally required medical records | See §9 |
4. No clinical decision support
MyOPD contains no clinical decision support of any kind. It does not:
• suggest a diagnosis from symptoms
• suggest, default or calculate a drug dose
• check for drug-drug interactions
• check for allergies or contraindications
• warn about duplicate therapy
• flag an abnormal result
• check a prescription against a patient's age, weight, pregnancy status or renal function
• apply any clinical rule, guideline or protocol
The absence of a warning means nothing. The system has no clinical knowledge and cannot warn you.
This is the most important line in this document to internalise. Clinicians who have used systems with interaction checking sometimes assume, without articulating it, that a system would say something if a combination were dangerous. MyOPD will not. It will print exactly what is entered, however wrong.
Every check that a prescribing system might perform must be performed by the doctor, using their own knowledge and their usual reference sources.
5. The drug master
- The drug list is a convenience list for fast entry, maintained by the clinic. It is not a formulary, not a therapeutic guide, and not verified by Caresoft.
- Where Caresoft supplies a starter drug list, it is offered as a starting point only, without warranty as to completeness, currency, correctness of spelling, strength or availability. The clinic must review and maintain it.
- Any default strength, frequency or duration stored against a drug is a data entry shortcut recorded by the clinic — not a clinical recommendation by Caresoft and not appropriate for every patient.
- A drug appearing in the list does not mean it is licensed, available, appropriate, or safe for a given patient.
- The clinic is responsible for removing withdrawn or banned drugs from its list. The system does not know about regulatory action.
Selecting from a list is not the same as verifying. Similar drug names sit next to each other in an autocomplete. The doctor must confirm the drug, strength and formulation on the finished prescription before signing it.
6. The printed prescription
A prescription is a legal document. Its content, legality and appropriateness are the prescribing doctor's responsibility, and it must comply with the Drugs and Cosmetics Act, 1940 and Rules, the applicable professional conduct regulations, and — for controlled substances — the Narcotic Drugs and Psychotropic Substances Act, 1985 and its rules.
- MyOPD prints what is entered. It does not validate legality, completeness or appropriateness.
- The doctor must review the printed prescription before it is given to the patient. What matters legally is what is on the paper the patient carries, not what is on the screen.
- The clinic is responsible for configuring the print format to include everything its regulator requires, including the practitioner's name, qualification and registration number.
- Where a signature is applied electronically, the clinic is responsible for ensuring the method is lawful and that no prescription can be signed without the doctor's authorisation. Signature credentials must never be shared.
- Where a prescription is corrected after issue, the clinic must follow a proper amendment process. The audit trail retains the original — corrections are recorded, not erased.
- Schedule H, H1 and X drugs and narcotics carry additional record and prescription requirements. The system does not enforce them.
7. The practitioner's responsibility
Nothing in MyOPD reduces, shares or transfers the treating practitioner's professional and legal responsibility for the care of their patient.
- The doctor is responsible for the diagnosis, the treatment plan, the prescription and the advice, regardless of what the software recorded or printed.
- The doctor must satisfy themselves that the record accurately reflects the consultation before finalising it.
- Clinical judgement always prevails over anything in the system. Where a record looks wrong, the patient in front of the doctor is the authority.
- Professional conduct obligations — consent, confidentiality, record-keeping, advertising — remain the practitioner's and the clinic's.
8. Telemedicine
Where a clinic uses MyOPD in connection with a consultation that is not face-to-face, the Telemedicine Practice Guidelines, 2020 apply to that consultation.
- Those Guidelines govern practitioner identification, patient consent, the categories of medicine that may be prescribed remotely, and record-keeping. MyOPD does not enforce them.
- The Guidelines restrict which drugs may be prescribed in a teleconsultation. The system will print whatever is entered and applies no such restriction.
- The clinic and the practitioner are responsible for compliance, including determining whether a remote consultation is appropriate at all.
- MyOPD is a record-keeping system, not a telemedicine platform, and provides no video, no identity verification and no consent workflow of its own unless separately stated in your Order.
9. Medical records and retention
MyOPD is not a substitute for the clinic's legal obligation to maintain medical records.
- Clinics are required to maintain outpatient records for the period prescribed by applicable law and professional regulation — under the professional conduct regulations, generally not less than three years from the last consultation, and longer where the Clinical Establishments Act rules of the relevant State, a court, or a specific circumstance requires it.
- Records relating to a minor, or to any matter under litigation or complaint, must be retained well beyond the ordinary period. Do not configure automatic deletion without advice.
- The clinic sets retention within the product and is responsible for setting it lawfully. Caresoft does not set it for you and cannot advise on it.
- Statutory retention overrides a deletion request, including a request from a patient. Where a patient asks for erasure, the clinic must assess what it is legally required to keep.
- Records must be producible on demand to a court, a consumer forum, a medical council or a lawful authority. Export your data regularly and do not rely on a single system as your only copy.
10. Downtime and paper fallback
Every clinic must maintain a workable paper fallback and must be able to see patients without the system.
Software is unavailable sometimes — power, internet, hardware, maintenance, a provider outage. A clinic that cannot function on paper for a morning has a patient safety problem, not an IT problem.
- Maintain printed prescription pads and a manual register, and ensure staff know where they are and how to use them.
- Keep a printed or offline copy of the day's appointment list.
- Have a documented procedure for entering paper records into the system after service is restored, marked as retrospective entry.
- Never delay treatment or refuse to see a patient because the system is unavailable.
- Test the fallback periodically. An untested fallback is not a fallback.
11. Data accuracy and identity
- The system stores what is entered. It does not verify identity, does not detect that two records are the same person, and does not know that a value is implausible.
- Confirm patient identity at every consultation using at least two identifiers, before opening a record and before issuing a prescription. Similar names are common and the system will not warn you.
- Duplicate records occur. The clinic is responsible for detecting and merging them; a merged record's history is retained in the audit trail.
- Where data is imported from a previous system, the clinic must verify it before clinical use. Imported data is not validated by Caresoft.
- Free-text fields are stored as typed, including errors. Any spell-checking, where present, is not clinically aware.
12. ABDM and ABHA
- Where the clinic enables ABDM features, exchange occurs under the ABDM framework and the Health Data Management Policy, using the patient's ABHA and the consent mechanism ABDM specifies.
- Linking and sharing require the patient's consent through ABDM. The clinic is responsible for obtaining it properly and for not pressuring a patient into it — ABHA is voluntary and care must not be conditioned on it.
- Records shared to other facilities pass out of the clinic's control. Caresoft cannot retrieve, correct or withdraw a record already delivered to another participant.
- Compliance certification status of the product is as stated in our current published material. Do not represent a certification we have not obtained.
13. Training and configuration
- Only trained users should operate the system. The clinic is responsible for ensuring training before a user is given access, and re-training after a significant change.
- Configuration choices — masters, print formats, roles, retention, defaults — have clinical consequences. The clinic administrator is responsible for them, and should review them at least [annually].
- Access must be individual. Shared logins destroy the audit trail that shows who recorded and who prescribed, which is precisely the evidence a clinic needs if a case is ever brought.
- Access must be revoked within [24] hours of a person leaving.
14. Reporting a safety concern
If you believe the software has behaved in a way that could affect patient safety — a prescription printing incorrectly, data appearing against the wrong patient, a record not saving — report it immediately to [email protected] and to your support contact.
Report it even if no harm occurred. A near miss reported early is how the next one is prevented.
- Safety reports are acknowledged within [4] working hours and triaged ahead of routine support.
- We will investigate, tell you what we find, and issue a corrective action and, where relevant, a notice to other clinics.
- Preserve the evidence — do not delete the affected record. The audit trail is needed.
- Where an incident may have caused patient harm, the clinic must also follow its own incident and disclosure obligations. That is not something we can do for you.
15. Regulatory position
[TO BE COMPLETED BEFORE COMMERCIAL RELEASE]
State here the product's position under the Medical Devices Rules, 2017 and any CDSCO requirement, and the basis for that position.
MyOPD as described in this Statement performs no clinical decision support (§4) and is intended as administrative record-keeping software, which is the basis on which it sits outside software-as-a-medical-device classification. That position depends entirely on §4 remaining true.
If any future release adds dose suggestion, interaction checking, allergy warnings, risk scoring or any other clinical rule, the classification must be reassessed before that feature ships. This is not a documentation task to complete afterwards.
The clinic remains responsible for its own registrations and compliance, including under the Clinical Establishments (Registration and Regulation) Act, 2010 where applicable in its State, and for biomedical waste, pharmacy and other licences relevant to its practice.
16. Changes to intended use
This Statement is versioned. Material changes to intended use, or the addition of any feature that would extend it, are notified to clinics in advance with an updated Statement and, where appropriate, updated training.
Clinics must not use MyOPD outside the intended use in §1, and must not rely on it for anything in §3.