+91 99620 16424

maimoonalegal@apollohospitals.com

Suite #21D,TVH Triveni Apartments, C V Raman Road,Alwarpet, Chennai - 600 018

KNOW YOUR LAW

Dear Apollo Family, 

The Telemedicine Practice Guidelines, 2020, allow an  RMP to prescribe non schedule drugs by a photo, scan,  digital copy of a signed prescription or E-Prescription to  a patient via email or any messaging platform.  

However, The Information Technology Act, 2000  mandates that if information is digitally transmitted and  requires authentication by a signature then a “digital signature” should be affixed on such document. 

An Act will override any Guidelines and in this case opens the doors on a discussion whether every RMP has to have a digital signature to be able to prescribe a digitally transmitted prescription. 

Read on to understand the interplay of the laws on the subject.  

Look forward to your views and feedback!

Sincerely

Maimoona Badsha

E-PRESCRIPTIONS & LEGAL REQUIREMENT  OF A DIGITAL SIGNATURE

The COVID-19 virus outbreak affected every facet of our lives, and the highest impact  was felt on the health and delivery of healthcare services. ‘Telemedicine services’, albeit  in existence for several decades, became an important component of medical practice. 

With the passing of the Telemedicine Guidelines, 2020 a legal framework for the remote  monitoring of patients was put in place. An issue that has arisen for consideration is: 

What is the permissible mode of an E-prescription and specifically the legal form of a  physician’s signature on an electronically delivered document such as this? 

Relevant Provisions of Law 

A.The Electronic Health Record Standards, 2016: 

These Standards issued by the Ministry of Health and Family Welfare specify that the Pharmacy  Practice Regulations, 2015 are the standard for ‘E-prescriptions’. 

B.The Pharmacy Practice Regulations, 2015: 

  • What is a Prescription? 

A ‘prescription’ is defined to mean a written or electronic direction from a Registered Medical  Practitioner or other properly licensed practitioners such as a Dentist, Veterinarian, etc. to a  Pharmacist to compound and dispense a specific type and quantity of preparation or prefabricated  drug to a patient. 

  • Contents of a Prescription? 

The contents of the Prescription include inter alia the details of the prescriber, patient, date,  medication, directions, and prescriber’s signature. 

Therefore, the Regulations acknowledge the electronic directions given by a prescriber to a  patient and mandate the signature of the prescriber for a valid prescription. 

C.Telemedicine Practice Guidelines, 2020 

What is the Mode of Prescription? 

  • RMP shall provide photo, scan, digital copy of a signed prescription or e-Prescription to the  patient via email or any messaging platform. 

D.The Information Technology Act, 2000 

What Are the Mandatory Requirements of a “Signature” under the Act? 

The Act provides that information shall be authenticated by:  

(i)affixing the signature; 

(ii)be signed; 

(iii)bear the signature  

then, notwithstanding anything contained in such law, such requirement shall be deemed to be  satisfied by means of a digital signature affixed on such document. 

Therefore, although the Telemedicine Guidelines do not mandate a Digital Signature, the IT Act,  2000 mandates that all information provided in a digital format is to be authenticated by a digital  signature. The latter is the substantive law on this subject and cannot be overridden by the  Guidelines.

Conclusion 

The legal position on the subject matter as it stands today is to affix a digital signature  on an e-prescription so as to accord requisite authenticity and legitimacy to the same.