Year : 2020 | Volume
: 5 | Issue : 2 | Page : 117--119
The wait is over: Switch from hardcopies to E-Copies
Consultant & Head-Transfusion Medicine, Manipal Hospital, Bangalore, Karnataka, India
Consultant & Head-Transfusion Medicine, Manipal Hospital, Bangalore, Karnataka
|How to cite this article:|
Chandrashekar S. The wait is over: Switch from hardcopies to E-Copies.Glob J Transfus Med 2020;5:117-119
|How to cite this URL:|
Chandrashekar S. The wait is over: Switch from hardcopies to E-Copies. Glob J Transfus Med [serial online] 2020 [cited 2021 Mar 2 ];5:117-119
Available from: https://www.gjtmonline.com/text.asp?2020/5/2/117/300616
According to the World Bank, electronic governance (E-governance) is when government agencies use information and communication technologies to transform relations with citizens, businesses, and other government agencies. One of the prime objectives of the Information Technology (IT) Act, India, 2000 is the promotion of electronic governance.
Readers of GJTM will agree that E-governance is more than just a government website on the Internet. The primary objective of e-governance is to support and simplify governance for all stakeholders, government, citizens, businesses, and nongovernmental organizations. Adoption of E-practices in all fields, including blood centers, will make record keeping more transparent, more traceable, and retention period nearly eternal. E-governance is synonymous with good governance. Good governance can be seen as an exercise of economic, political, and administrative authority to better manage affairs of a country at all levels and seeks to build better bonding between the government and the public. Unfortunately, the implementation of E-governance at the blood center level in Asian countries is lagging behind. Let us examine the laws of one country.
The IT Act passed by most governments is based on Model Law on Electronic Commerce adopted by the United Nations Commission on International Trade Law vide resolution A/RES/51/162, dated January 30, 1997. The Indian IT Act was passed by the Government of India to provide legal recognition for the transactions carried out by means of electronic data interchange and other means of electronic communication.
Consequent to this came the various applications that we use today in India like the M-Parivahaan to maintain legally acceptable electronic records of your vehicle-related documents such as ownership, driving license, insurance, and pollution certificates. Then, we have a digilocker which links with you almost anything under the sun-Insurance policies, vehicle documents, your national ID (AADHAR) cards, your income tax records (PAN number), education-related documents such as your marks card, migration certificates, degree certificates, health records of some hospitals.
Today, sitting at home you can open a bank account, book a health check at home, order pizza from McDonalds, order books to read from Just books, get test reports delivered to your phone, and pay for all these by electronic methods. Not just this, records of what purchases you made, your invoices, warranties can all be retrieved at will, thanks to e-commerce platforms such as Amazon and Flipkart. Thanks to COVID 19, you can book an appointment with a doctor, get your e-prescription delivered to your phone, and order medicines online using your e-prescription and pay for it online. E-commerce has made all this possible. Gone are the days when you needed money in your pocket. Money in your bank is all that you need.
Why are we discussing so much about the IT Act? Of what relevance is it to us as Transfusion Medicine experts? Yes, the passage of the IT Act and the improvements to it are of no consequence to us in the blood center. We are governed by a more draconian Drugs and Cosmetics (D&C) act passed before the Independence in 1940 which asks for maintenance of hard copies of most blood center records. The D&C Act stipulates that the donor register, the component register, the issue register, the master register, the donor forms, the blood stock registers, the reagents, and the bag inventories all be maintained as hard copies. However, do you know that Section 4 of the Indian IT Act, 2000 confers legal recognition to electronic records, Section 5 allows electronic signatures, and Section 7 allows retention of electronic records akin to paper-based records to fulfill legal requirement of retention of records. This IT Act specifies that notwithstanding anything contained in any other law, the IT act will prevail upon them.
What does the Indian Information Technology Act say?
Section 4: Legal recognition of electronic records
Where any law (in our case the D&C Act) provides that information or any other matter shall be in writing or in the typewritten or printed form, then, notwithstanding anything contained in such law, such requirement shall be deemed to have been satisfied if such information or matter is –
Rendered or made available in an electronic formAccessible so as to be usable for a subsequent reference.
Section 5: Legal recognition of electronic signatures
Where any law provides that information or any other matter shall be authenticated by affixing the signature or any document shall be signed or bear the signature of any person, then, not with standing anything contained in such law, such requirement shall be deemed to have been satisfied, if such information or matter is authenticated by means of electronic signature.
Section 3A: Electronic signature
For the purposes of this section, any electronic signature or electronic authentication technique shall be considered reliable if (a) the signature creation data or the authentication data are, linked to the signatory/authenticator and to no other person; (b) the signature creation data or the authentication data were, at the time of signing, under the control of the signatory/authenticator and no other person; (c) any alteration to the electronic signature or any alteration to the information made after affixing such signature is detectable.
Secure 15: Secure electronic signature
An electronic signature shall be deemed to be a secure electronic signature if (i) the signature creation data, at the time of affixing signature, was under the exclusive control of signatory and no other person and (ii) the signature creation data was stored and affixed in such exclusive manner as may be prescribed.
Section 7: Retention of electronic records
Where any law provides that documents, records or information shall be retained for any specific period, then, that requirement shall be deemed to have been satisfied if such documents, records or information are retained in the electronic form, if:
The information contained is accessible/usable for a subsequent referenceThe electronic record is retained in the format in which it was originally generated, sent, receivedThe details which will facilitate the identification of the origin, destination, date and time of dispatch, or receipt of such electronic record are available in the electronic records.
Attribution of electronic records
An electronic record shall be attributed to the originator if it was sent – (a) by the originator himself; (b) by a person who had the authority to act on behalf of the originator in respect of that electronic record; or (c) by an information system programmed by or on behalf of the originator to operate automatically. Blood issues done by blood center staff on behalf of the medical officer fall in this category.
With this background, do we need:
Hard copies of signed donor forms?Hard copies of blood request forms – Is MCI, now NMC registration with electronic signatures not good enough to trace the doctors?Hard copies of registers?Signed documents/registers?What is better 5-year retention of hard copies or longer retentions as soft copy?
The IT Act of 2000 with subsequent amendments overrides our D&C Act of 1944. The IT Act not only tells you what you are permitted to do but also specifies punishment.
Section 66C: Punishment for identity theftSection 66D: Punishment for cheating by personation by using computer resourceSection 66E: Punishment for violation of privacy.
The first schedule of IT Act 2000 also clearly mentions exceptions to the act ie documents which need to be maintained as hard copies. These include Negotaible instruments (cheques, bonds etc), power of attorney, Trust deed, will and contract for sale of immovable property. It is therofe clear that as per IT act blood centre can maintain softcopies of records and registers and this superceded the D and C act/rules.
The time has come to throw all our forms and registers into the dustbin, enable donors to fill up donors forms online either at home or in the blood center, undergo e-counseling or one to one counseling based on his/her comfort, provide as much IEC/motivational materials as possible to the donor through his/her mobile phone, and maintain all data confidentially stored with limited access to only blood center staff authenticated by the medical officers by means of electronic signatures with traceability of data and changes made to it with date and time being captured. This will make our data more secure and operations more transparent than the use of hard copies. Patients need not go back to faraway hospitals to fetch the blood request forms signed by their doctors as long as it is authenticated by them in software with traceability. You need not issue hard copies of compatibility reports signed in pen, softcopies with electronic signature of the issuer/designee will do.
Of course, where IT support is inadequate, hardcopies can continue to be used. However, the IT Act of 2000 and subsequent amendments supersede the D&C Act requirement of hard copies and signatures. Clarifying this in the D&C Act itself will go a long way in easing blood center operations and pave the way for transparent traceable operations and ensure better recordkeeping that can be retrieved at will without having to bother about pest control of hard copies.
Use of IT in blood center should be facilitated by regulators/not hindered, not only in the Indian subcontinent but also in the whole of Asia. We do not want to be left behind the rest of the world. Let us focus on better patient and donor care. Let our systems take care of record keeping. Current blood banking software can completely eliminate record keeping and put all records and data at our fingertips. If the banking sector can transact crores of rupees with only electronic signatures, can't we issue blood with it? The IT Department, National Accreditation Board of Hospitals and Healthcare providers, the transport department, and the universities all have gone paperless. Let us not be left behind in the race to save our trees, our planets, and humankind. Do not write or print on paper. Use IT as a tool to facilitate work for yourself and for the regulators. However, beware that only 1% of the IT returns are scrutinized. In contrast, 100% of blood centers are already under scrutiny at the time of licensing inspections.
|1||Electronic Record and E-Governance. Available from: https://www.toppr.com/guides/business-laws-cs/cyber-laws/electronic-record-and-e-governance/. [Last accessed on 2020 Nov 03].|
|2||Information Technology Act, 2000 (India). Available from: https://www.geeksforgeeks.org/information-technology-act-2000-india/. [Last accessed on 2020 Nov 03].|
|3||The Information Technology Act, 2000. Available from: https://indiankanoon.org/doc/1965344/. [Last accessed on 2020 Nov 03].|
|4||The Drugs and Cosmetics Act 1940 and Rules 1945. Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf. [Last accessed on 2020 Nov 03].|