March 06 | 2017
*Medical record-keeping and the law in India*
(Dr. Chandrashekhar Sohoni)
Deficient or inaccurate record-keeping is, by far, the commonest reason for legal sufferings of Indian doctors. Most of the penalisation of doctors, whether under Consumer Protection Act or Pre-conception and Pre-natal Diagnostic Techniques Act, is based on defective record-keeping.
Following are the various legal provisions which mandate medical record-keeping by doctors and hospitals in India:-
1)–The Ethics Code Regulations, 2002 prescribed by Medical Council of India (MCI) under Indian Medical Council Act, 1956, regulation 1.3.1 states as follows:-
“1.3.1. Every Physician shall maintain the medical records pertaining to his / her indoor patients for a period of 3 years from the date of commencement of treatment in a standard proforma laid down by medical council of India and attached as Appendix 3.”
2)–The Clinical Establishment Act (CEA), 2010, section 12(1)(iii) provides for maintenance of medical records as a pre-requisite for initiation and continuation of registration of a clinical establishment under this Act. Since the CEA is a central Act that is optional for States, the rules framed under the Act by the adopting States will vary. However, there is a general guideline under CEA Rules, 2012 as follows:
“Copies of all records and statistics shall be kept with the clinical establishment concerned for at least 3 or 5 years or in accordance with any other relevant Act in force at the time under Section 12(1)(iii).”
3)–As per the provisions of the Limitation Act, 1963, civil suits for claiming damages can be instituted within 3 years of causation or discovery of damage, whichever is later. Thus, ordinarily, a patient aggrieved by an act of negligence of a doctor can file a civil case within a period of 3 years. However, under section 14 of the Limitations Act, the court can condone the delay in filing a case if the court is of the considered opinion that such delay is justified. Hence, a patient may be able to initiate legal action even after 3 years. This is especially important in cases of negligence related to pediatric patients. A patient who has suffered damage due to negligence of a doctor in childhood can initiate legal proceedings upon achieving adulthood. In such cases, courts may direct the doctor to present medical records which may be few decades old!
4)–As per section 24A(1) of the Consumer Protection Act (CPA), 1986, a consumer forum is allowed to admit a complaint only if the complaint is made within 2 years of the date of cause of action. Thus, under the CPA, a patient can ordinarily file a complaint against alleged negligence by a doctor within 2 years of the negligent act. However, under section 24A(2), the consumer forum can condone the delay in filing of a complaint if the forum is of the considered opinion that such delay is justified. Thus, a patient may be able to claim compensation via CPA even after 2 years. And in such a case, the consumer forum may direct the doctor to present medical records which may be few decades old!
5)–The Directorate General Health Services, Ministry of Health and Family Welfare (MOHFW) has specified period for which medical records should be preserved by hospitals (vide letter 10/3-68-MH, dated 31-08-1968) in Chapter XII of the Hospital Manual, 2002, as under:-
In-patient records — 10 years
Out-patient records — 5 years
Medico-legal records — 10 years
6)–Under the Pre-conception and Pre-natal Diagnostic Techniques (PCPNDT) Act, 1994, all prescribed records under the Act need to be preserved for a period of 2 years, and, in the event of a pending court case, till the final disposal of the case.
7)–Under the West Bengal Clinical Establishment Rules, 1951, (rule 18), all medical records need to be preserved for a minimum period of 5 years.
8)–As per Punjab Medical Manual (1934), medical records are to be preserved for 12 years.
9)–As per Income Tax Rules, 1962, Rule 6F(3), a medical professional needs to keep and maintain for a period of 6 years from the end of relevant assessment year, the following:-
(i) A daily register of patients in Form 3C.
(ii) An inventory of the stock of drugs, medicines and other consumable accessories used for the purpose of his profession, as on the first and the last day of the previous year.
Thus, in this article, I have summarised the various laws in India which mandate time-bound record-keeping, both for in-patient as well as out-patient services. In my articles to come next, I shall discuss as to why accuracy of medical records in legally imperative, and how that can influence outcomes in medico-legal cases.
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Reproduced by : Dr. Deepak Baid