JSA Newsletter – Health – Lexology


India’s healthcare ecosystem is changing rapidly. In August, several guidelines were released to improve the health care plan. This reading briefly captures the essence of the following guidelines –

  1. Guidelines for the Implementation of the Ayushman Bharat Digital Mission.
  2. Guidance document for the implementation of laboratory services.
  3. Revised guidelines for the production-linked incentive program for the promotion of domestic manufacturing of medical devices.
  4. Recognition of the success of AI-based technologies.

Guidelines for Healthcare Institutions for Implementing the Ayushman Bharat Digital Mission

On August 22, 2022, the National Health Authority issued material guidelines for health institutions such as hospitals, clinics and health and wellness centers to promote digitalization in hospitals (the “ Scanning Guidelines”). The Digitization Guidelines provide a basic framework for States/Union Territories to plan, evaluate, and acquire hardware (including specifications for various hardware equipment) to operate digital mission-compliant applications. by Ayushman Bharat. Digitization guidelines are recommended in nature and local governments have the flexibility to modify them based on local requirements and circumstances.

Using Ayushman Bharat Digital Mission in healthcare facilities offers many benefits. The latest technologies will replace the time-consuming and labor-intensive manual approach, which results in a highly coordinated and organized treatment process. Patient data is also secure on always-recoverable systems. The organized process further enables healthcare workers to provide better and more efficient care to patients. Additionally, medical errors due to manual data entry will be eliminated with the adoption of a digital healthcare ecosystem.

The digital ecosystem will also enable a host of other facilities such as teleconsultation, paperless health records, QR code based outpatient service records, etc.

Guidance document for the implementation of laboratory services

On August 5, 2022, the MoHFW, had published the guidelines for the implementation of laboratory services (the “Guidance document”). For the effective implementation of services, its components, such as list of tests provided in health facilities, gap analysis of existing equipment, operating model, supply chain, procurement, human resources , quality control and data management must be robust. The guidance document recommends an expanded range of diagnostics at all levels of public health settings providing for a minimum set of essential diagnostic tests according to the list of essential diagnostics. The guidelines issued there relate to the “Free Diagnostics Service Initiative” (“FDSI”) as part of the National Health Mission launched in July 2015 with the aim of providing accessible and affordable pathological and radiological diagnostic services closer to the community, reducing out-of-pocket expenses.

As part of the National Heath Mission, FDSI is provided through various modes such as (a) in-house; (b) public-private partnership; and (c) hybrid mode by states/UTs across the country. Free laboratory services are operational in 33 (thirty-three) states/union territories, of which 11 (eleven) states/union territories provide the services through the in-house mode. Likewise, the free teleradiology service is operational in 11 (eleven) States/Union Territories via the internal mode. The guidance document is available at https://www.nhm.gov.in/New_Updates_2018/NHM_Components/Health_System_Stregthening/Comprehensive_primary_health_care/letter/Guidance_document_for_Free_Laboratory_Services.pdf.

Revised Guidelines for the Production-Related Incentives Program for the Promotion of Domestic Manufacturing of Medical Devices

On August 18, 2022, the Department of Pharmaceuticals of the Ministry of Chemicals and Fertilizers revised the Production Incentive Guidelines (“IPL” “Revised LIP scheme”) originally published on July 21, 2020 (later revised on October 29, 2020). The revised PLI program provides a financial incentive for licensed medical device manufacturers to stimulate domestic manufacturing and attract large-scale investment in the medical device segments.

Under the revised PLI program, applications have been invited for medical devices classified into 2 (two) categories, namely Category A and Category B. Category A products include Cobalt Rotary Machine, Linear Accelerator (LINAC), scanner, MRI, dialyzer, anesthesia unit ventilators, heart valves, stents, etc. On the other hand, Category B products include brachytherapy systems, radiation therapy simulation systems, cyclotrons, anesthesia-needles, anesthesia-syringes, anesthesia kits, cochlear implants, spinal systems and surgical neuro-implants, etc. The classification of eligible products in the two categories (i.e. Category A and Category B) is made on the basis of the 4 (four) segments they cater to. These are: (a) cancer treatment/radiation therapy medical devices; (b) radiology and imaging medical devices (ionizing and non-ionizing radiation products) and nuclear imaging devices; (c) anesthetics and cardiorespiratory medical devices, including cardiorespiratory grade catheters and renal medical care; and (d) all implants, including implantable electronic devices.

Any Category A or Category B application can be made by a global manufacturing company. Different turnover thresholds are prescribed for the 2 (two) categories mentioned above, which are as follows: (a) for applicants to be eligible in category A, the turnover of the company and/or the group company for the financial year ended 2018-19 must be INR 60,00,00,000 (Indian rupees sixty crore) or more; and (b) to be eligible to apply under Category B, the turnover of the company and/or group company for the closed financial year 2018-19 must be INR 20,000,000 (Twenty Crore Indian Rupees) .

For candidates eligible to apply under Category B of the revised PLI scheme, applications can be made between September 1, 2022 and October 31, 2022.

The revised PLI scheme is available at https://pharmaceuticals.gov.in/sites/default/files/Revised%20Guidelines%20of%20PLI%20Medical%20Devices%20dated%2018.08.2022.pdf

Recognition of the success of AI-based technologies deployed under Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana

On August 2, 2022, the MoHFW disclosed in a press release its zero-tolerance approach to any type of fraud under the Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (“AB-PMJAY”). The Indian government takes a proactive approach to combating fraud and abuse. The MoHFW highlighted several countervailing strategies that have been employed under AB-PMJAY to combat various types of fraud and further recognizes the success of the artificial intelligence-based technologies deployed under the program.

The National Health Authority is the implementing agency for AB-PMJAY which has issued a comprehensive set of anti-fraud guidelines. Aadhar-based biometric verification feature of beneficiary at time of admission and discharge has been launched in all private hospitals. The MoHFW noted that the use of artificial intelligence and machine learning has provided a comprehensive fraud analytics solution to proactively detect fraud, develop algorithms that can be used on a large volume of data to identify suspicious transactions and entities and risk scoring of hospitals and claims. .

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