Tag: Regulations

Industry Update – Guidance Document published by FDA for Small Entities

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Small Entity Compliance Guide – Guidance Document published by FDA

FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (“LDT Final Rule”), amending FDA regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory . 

The FDA has published a Guidance document for small entities –  “Small Entity Compliance Guide” to assist small entities to comply with the  requirements established in FDA regulations as they apply to IVDs, including LDTs.

Click here to read the Guidance Document

Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laboratory-developed-tests-small-entity-compliance-guide

Industry Information Update

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Guidelines for the Prevention and Regulation of Unsolicited and Unwarranted Business Communication, 2024

The Central Consumer Protection Authority (CCPA) has issued the “Guidelines for the Prevention and Regulation of Unsolicited and Unwarranted Business Communication, 2024” to protect consumers from unfair trade practices and violations of their rights through unsolicited business communications.

These guidelines apply to all entities involved in making, engaging, or benefiting from such communications and outline specific conditions under which business communications are considered unsolicited and unwarranted.

Key Takeaways

  1. Scope and Applicability
    The guidelines apply to all persons or establishments involved in making, engaging, or benefiting from business communications.
    Business communications include voice calls, SMS, and instant messaging through social media platforms.
  2. Definitions
    “Business Communication” refers to communication related to goods or services, excluding personal communication.
    “Unsolicited and Unwarranted Business Communication” is defined as any communication for sale or promotion of goods and services that is neither as per the consent nor the registered preferences of the recipient.
  3. Conditions for Violation
    Using number series or SMS headers not prescribed by the Telecom Regulatory Authority of India (TRAI) or the Department of Telecommunications (DoT).
    Ignoring consumer requests to opt-out of communications registered in the Do Not Disturb (DND) registry.
    Failing to obtain explicit and specific digital consent from consumers.
    Not clearly identifying the calling entity and the purpose of the call.
    Using unauthorized employees or agents for making calls.
    Not providing a clear, simple, free, and effective opt-out option for consumers.
  4. Illustrations
    Examples provided clarify scenarios where multiple entities (e.g., banks, fintech companies, intermediaries) are involved in unsolicited communications and how the guidelines apply to each.
  5. Non-Derogation Clause
    The guidelines are in addition to, and not in derogation of, other existing laws regulating unsolicited communications.
  6. Penalties
    Any contravention of these guidelines will be subject to the provisions of the Consumer Protection Act, 2019.
  7. Final Authority
    In case of any ambiguity or dispute in interpretation, the decision of the CCPA will be final.
  8. Public Feedback
    The CCPA has sought public comments on the draft guidelines, with the last date for submission being July 21, 2024 by email to js-ca@nic.in

These guidelines aim to curb the proliferation of spam and fraudulent calls, ensuring that consumers are not subjected to invasive and unauthorized marketing communications.

Click here to read the guidelines

Source: https://consumeraffairs.nic.in/

𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠 𝐨𝐟 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐅𝐮𝐧𝐜𝐭𝐢𝐨𝐧 – RBI Notification

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𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠 𝐨𝐟 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐅𝐮𝐧𝐜𝐭𝐢𝐨𝐧 – 𝐋𝐞𝐯𝐞𝐫𝐚𝐠𝐢𝐧𝐠 𝐔𝐬𝐞 𝐨𝐟 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲

Reserve Bank of India (RBI) has released a circular titled “𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠 𝐨𝐟 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐅𝐮𝐧𝐜𝐭𝐢𝐨𝐧 – 𝐋𝐞𝐯𝐞𝐫𝐚𝐠𝐢𝐧𝐠 𝐔𝐬𝐞 𝐨𝐟 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲” few months ago, providing several key insights and directives for various financial institutions in the country, as listed below :

𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐨𝐟 𝐂𝐮𝐫𝐫𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦𝐬:

– RBI conducted an assessment of the internal compliance monitoring systems in select Supervised Entities (SEs).
– It was found that SEs use varying levels of automation, from macro-enabled spreadsheets to workflow-based software solutions.
– The review highlighted that many compliance monitoring processes still involve significant manual intervention.

𝐍𝐞𝐞𝐝 𝐟𝐨𝐫 𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬:

– There is a need for SEs to implement comprehensive, integrated, enterprise-wide, and workflow-based solutions/tools to enhance the effectiveness of compliance monitoring.
– Such solutions should facilitate effective communication and collaboration among all stakeholders, including business, compliance, IT teams, and senior management.

𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐬 𝐨𝐟 𝐭𝐡𝐞 𝐏𝐫𝐨𝐩𝐨𝐬𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬:

– The solutions/tools should include processes for identifying, assessing, monitoring, and managing compliance requirements.
– They should be capable of escalating issues of non-compliance and require recording approval for deviations or delays in compliance submission.
– A unified dashboard view should be provided to senior management to give an overall compliance position of the regulated entity.

𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐓𝐢𝐦𝐞𝐥𝐢𝐧𝐞:

– Regulated Entities (REs) are advised to carry out a comprehensive review of their existing internal compliance tracking and monitoring processes.
– Necessary changes to existing systems or the implementation of new systems should be completed by June 30, 2024.

𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐌𝐞𝐜𝐡𝐚𝐧𝐢𝐬𝐦:

An appropriate monitoring mechanism should be put in place to review the progress of the implementation of these new systems or changes.

These directives aim to standardize and improve the internal compliance monitoring functions across various financial institutions by leveraging advanced technological solutions.

The RE, based on the size and complexity of its operations, may decide on the tools/ mechanism it would prefer to deploy for monitoring of compliance and development of the unified dashboard.

Click here to read the Notification

Source: https://www.rbi.org.in/

Curriculum and Credit framework for PG programs

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Curriculum and Credit Framework for
Postgraduate Programmes

The University Grants Commission (UGC) has introduced a curriculum and credit framework for Postgraduate (PG) programs in line with the National Education Policy (NEP) 2020. The framework aims to provide an flexible, multidisciplinary and student-centric model for postgraduate education in line with NEP 2020 recommendations.

Key feature details are given below :

Main Features of the PG Curriculum Framework

a. Flexibility to move from one discipline of study to another
b. Flexibility for students with a major and minor(s) in UG to opt for either major, minor(s) or any other subject in PG based on competence.
c. Opportunity for learners to choose courses of interest
d. Flexibility to switch between offline, online, distance and hybrid learning modes
e. Mobility and multiple entry/exit options facilitated by the Academic Bank of Credits

Credit Requirements and Eligibility

a. 160 credits from a Bachelor’s degree with Honours/Research for a 1-year/2-semester PG programme at NHEQF level 6.5
b. 120 credits from a 3-year Bachelor’s degree for a 2-year/4-semester PG programme at NHEQF level 6.5
c. 160 credits from a 4-year Bachelor’s degree like B.E/B.Tech for a 2-year/4-semester PG programme at NHEQF level 7

Programme Designs

a. 2-year PG with second year focused on research (after 3-year Bachelor’s)
b. 1-year PG after 4-year Bachelor’s with Honours/Research
c. Integrated 5-year Bachelor’s/Master’s programme

Curricular Components

a. For 2-year PG: Coursework only, research only, or coursework+research options
b. For 1-year PG: Coursework, research or coursework+research options
c. Specialized curricula for analytical/problem-solving focused programmes

Graduate Attributes

The NHEQF outlines graduate attributes like advanced knowledge, research skills, problem-solving abilities, communication skills and ethical responsibility.

Academic Flexibility

a. Students can pursue PG in major/minor discipline from UG
b. Can qualify through entrance exam in any PG discipline
c. Multiple entry/exit points and credit transfer between programmes

Assessment Strategy

Focus on formative and continuous assessment aligned with learning outcomes, as per UGC guidelines.

Click here to download the Framework

Source : https://www.ugc.gov.in/pdfnews/4682468_Curriculum-and-Credit-Framework-for-Postgraduate-Programmes.pdf

GUIDELINES FOR INTER-DEPARTMENTAL REFERRALS(WITHIN HOSPITAL)2024

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GUIDELINES FOR INTER-DEPARTMENTAL REFERRALS
(WITHIN HOSPITAL) 2024

Inter Departmental referral process is a crucial component of high quality comprehensive patient care in any Medical Institution. However there are inconsistencies and lack of accountability in the referral process. To address the various issues prevailing in the inter departmental referral process, Director General of Health Services, Ministry of Health & Family Welfare has issued Guidelines for Inter-Departmental Referral within a hospital.

These guidelines provide a framework to various hospitals to improve patient care services, facilitate better communication and cooperation between departments, enhance working relationships and help develop accountability in a hospital.

Hospitals should develop their internal Standard Operating Procedures using the guidelines issued by the Directorate.

DO’S AND DON’TS FOR INTER-DEPARTMENTAL REFERRALS AT HOSPITALS

DO’s

a. To Initiate referrals promptly
b. To document referrals accurately
c. Effective Communication
d. Acknowledge and update referrals
e. Collaborate for Continuity of Care
f. Follow up on referrals
g. Respect patient confidentiality
h. Seek feedback for improvement
i. Adhere to hospital policies and best practices
j. Prioritise patient centered care

DONT’s

a.Don’t delay referrals unnecessarily
b.Don’t omit essential clinical information or documentation
c.Don’t assume that all referrals are routine or non-urgent;
d.Don’t overlook communication
e.Don’t rely solely on verbal communication
f. Don’t hesitate to escalate urgent referrals
g.Don’t breach patient confidentiality
h.Don’t ignore feedback
i. Don’t overlook importance of ongoing education and training
j. Don’t lose sight of patient’s overall well-being

Click here to read the guideline document

Source: Ministry of Health & Family Welfare Directorate Guideline document

DRAFT AMENDMENTS TO THE CCI REGULATIONS, 2009

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DRAFT AMENDMENTS TO THE COMPETITION COMMISSION OF INDIA (GENERAL) REGULATIONS, 2009

CCI (Competition Commission of India) is amending its Regulations and the notification was released on June 6th 2024. Public Consultation is open and comments are invited from the public.

Consultation on draft ‘The Competition Commission of India (General) Regulations, 2009’ Back ground Note for the proposed amendment and proposed draft amendments are posted in the CCI’s portal. Sharing the links below for the same.


Background Note – https://cci.gov.in/images/stakeholderstopicsconsultations/en/background-note1717612208.pdf

Draft amendments – https://cci.gov.in/images/stakeholderstopicsconsultations/en/draft-amendments-to-the-cci-general-regulations-20091717612278.pdf

The stakeholders can submit written comments on the draft amendments to the Competition Commission of India (General) Regulations, 2009, within 30 (thirty) days from 06.06.2024 to 08.07.2024.

The stakeholders can submit their comments at the link shared below: https://cci.gov.in/stakeholders-consultations/30

source : https://cci.gov.in/stakeholders-topics-consultations

Master Circular on Health Insurance Business

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Master Circular on Health Insurance Business – Issued by IRDAI

The Insurance Regulatory and Development Authority of India (IRDAI) has issued a Master Circular on Health Insurance Business. This Master Circular shall come into force with immediate effect, except for provisions where specific effective dates are mentioned.

The key information for policyholders, prospects, and customers includes:

Insurance Product Availability: Insurance products are available with add-ons/riders, catering to all ages, existing medical conditions, preexisting diseases, and chronic conditions.

Technological Advancements Treatments: The latest technological advancements and treatments are made available to policyholders.

Customer Information Sheet (CIS): Insurance companies shall issue a CIS as a separate annexure, containing key information on the policy, such as type of insurance, sum insured, exclusions, waiting period, claims procedure, policy servicing, and grievance redressal mechanism

Free Look Period: A 30-day free look period is provided to enable policyholders to review the terms and conditions of the policy and cancel it if not satisfied.

Cancellation of Indemnity Policy: Policyholders can cancel their policy at any time during the term by giving 7 days’ notice in writing.

Nomination: Policyholders can register or change their nomination during the term of the policy.

Grace Period for Payment of Premium: A grace period of 15 days for monthly premiums and 30 days for quarterly, half-yearly, or yearly premiums is available. If the policy is renewed during the grace period, all accrued credits (sum insured, no claim bonus, specific waiting periods, etc.) shall be protected.

Insurance Coverage during Grace Period: Coverage is available during the grace period if premiums are paid in installments.

Renewal of Health Insurance Policy: A health insurance policy shall be renewable unless the product is withdrawn due to established fraud, non-disclosure, or misrepresentation by the insured. The insurer shall not deny renewal based on previous claims.

Migration in case of Indemnity Policies: Policyholders can transfer credits gained to the extent of the sum insured, no claim bonus, specific waiting periods,

Portability in case of Indemnity Policies: The existing insurer shall provide information to the acquiring insurer within 72 hours of receipt of the request. The acquiring insurer shall decide and communicate on the proposal within 5 days.

Policy/Claim cannot be Contested: Policies and claims shall not be contestable on grounds of non-disclosure and/or misrepresentation except for established fraud after the completion of the moratorium period (60 months of continuous coverage).

No Claim Bonus: Accumulated no claim bonus can be claimed by way of addition to the sum assured or discount in renewal premium.

Approval for Cashless Claims:

  • Insurers shall strive to achieve 100% cashless claim settlement in a time-bound manner. Authorization for cashless claims should be given immediately, not more than one hour of receipt of request.
  • Necessary systems and procedures shall be put in place by the Insurer immediately and not later than 31st July, 2024.
  • Insurers may arrange for dedicated Help Desks in physical mode at the hospital to deal and assist with the cashless requests.
  • Insurers shall also provide pre-authorization to the policyholder through Digital mode

Final Authorisation for Discharge from the Hospital : Final claim authorisation should be given within THREE hours of receipt of discharge authorisation request received. In no case, the policyholder shall be made to wait to be discharged from the Hospital.

Settlement of Claims: No claim shall be repudiated without the approval of the Claims Review Committee (CRC).

Claims in respect of Multiple Policies: In case the available coverage is less than the admissible claim amount, the primary insurer shall coordinate with other insurers to ensure settlement of the balance amount without causing any hassles to the policyholder.

Implementation of Ombudsman Award: Insurers are required to comply with the award of the Insurance Ombudsman within 30 days. Failure to comply may result in a penalty of Rs. 5000 per day.

The broad requirements to be complied with by insurers in the health insurance business, as outlined in the Master Circular, include:

General Principles:

  • Board-approved underwriting policy covering all ages and medical conditions.
  • Policy on quality standards and benchmarks for empanelment of hospitals and healthcare providers.
  • Ensuring Ayush treatments are at par with other treatments.
  • Striving to provide 100% cashless services to policyholders
  • Designing proposal forms in simple language and providing them in scheduled languages.
  • Disseminating information about products transparently to prospects and policyholders.
  • Mandatory forwarding of CIS in the specified format and obtaining acknowledgment from the policyholder

Claims Settlement : A well defined claims handling, claim settlement procedures, turnaround times (TATs) for settlement of claims and policy servicing

No claim should be repudiated without the approval of the Claims Review Committee (CRC) or the Policyholder Management Committee (PMC).

Display on Insurers Website:

  • List of hospitals / healthcare providers tie up for Cashless Claim and list of network hospitals
  • Procedures to be followed by the policyholder for claim settlement under cashless facility and reimbursement of claims
  • Turn Around Time for policy servicing, approvals of cashless as well as reimbursement claim settlement
  • List of products on offer and products withdrawn

Training and Technology Solutions:

  • Periodical training for intermediaries, distribution channels, and employees on products, TATs, and regulatory changes.
  • Implementation of end-to-end technology solutions for effective onboarding, policy servicing, and claim settlement

Performance Monitoring of TPAs:

  • Board-approved criteria for monitoring TPA performance, customer servicing, and service level parameters.
  • Feedback collection from customers on claims settlement.
  • Claw back of remuneration based on customer feedback.
  • Payments to TPAs only after satisfactory service discharge

Product Management Committee and Advertisement Committee:

  • Establishment of committees for product management and advertisement as per the regulations

Product Filing:

  • Insurers must follow a structured procedure for filing new products, riders, add-ons, or modifications, which requires approval from the Product Management Committee (PMC).
  • Details of individual and group products should be maintained in designated forms.

 Withdrawal of Products:

  • Insurers are required to inform the withdrawal of any products, add-ons, or riders within 30 days using the specified form.
  • The decision to withdraw a health insurance product/add-on/rider is made by the PMC, with clear documentation of the reasons for withdrawal.
  • Existing customers of a withdrawn product should be provided options to renew, migrate to another product, or choose suitable alternatives.
  • Distribution channels must be informed well in advance about product withdrawals.
  • Refunds for premiums or deposits received for withdrawn products should be promptly issued to policyholders 16.

Miscellaneous Provisions:

  • Model product for persons with disabilities, HIV/AIDS, and mental illness
  • With specific consent of the policyholder, Insurers may facilitate creation of ABHA number as per procedures laid down..
  • Submission of periodic returns on Premium, claims etc. as per the provisions of the master circular on submission of returns issued by the Competent Authority
Click here to read more

Source: https://irdai.gov.in/

Prevention and Maintenance of Fire Safety

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Prevention and Maintenance of
Fire Safety in Healthcare Facilities

Given the potential risks associated with fire hazards in hospitals, especially in this hot summer with rising temperature, it is imperative that strict protocols and measures be put in place to prevent, detect and respond to fire effectively. The Director General of Health Services, Ministry of Health and  Family Welfare has issued a detailed set of instructions and checklist to follow the proactive measures to prevent, detect and respond to fires effectively.

All the hospitals are directed to conduct regular preventive fire risk assessment drills to identify potentially vulnerable areas and

  1. Implement appropriate fire prevention measures, such as proper storage of flammable materials and regular and optimal preventive maintenance of electrical circuits and systems.
  2. Providing staff training on fire safety protocols, evacuation procedures, and use of fire-fighting equipment.
  3. Installation and optimum maintenance of fire detection and suppression systems, including smoke alarms, fire extinguishers, and sprinklers.
  4. Establishing an emergency response plan with SOPs for evacuating patients, staff, and visitors in the untoward event of a fire.
  5. Most importantly, regular conduct of mock emergency drills without compromise.

Click the button below to download the instructions & checklist issued by the Directorate.

Click here to read the instructions & Checklist

Source:https://dghs.gov.in/

SEC Rule on GHG Disclosures

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SEC Rule on GHG Disclosures

The SEC’s rule on climate-related disclosures, approved on March 6, 2024, is a significant step towards standardizing and enhancing the transparency of emissions reporting by companies. This rule mandates that companies provide detailed narratives regarding their identification, management, and oversight of climate-related risks, including disclosure of their scope 1 and scope 2 emissions. The disclosed information must be independently reviewed for credibility and accuracy, although scope 3 emissions are not initially included in the requirements.

Accredited validation and verification bodies (VVBs) play a crucial role in ensuring the credibility and reliability of emissions data reported by companies. While financial auditors are not the only entities permitted to perform assurance under the SEC rule, having experienced verification bodies following international best practices can significantly enhance the credibility of emissions disclosures. Accredited VVBs adhere to high standards of ethical conduct, impartiality, and sectoral competence, providing assurance that reported data is accurate and reliable.

ANAB’s Validation and Verification Accreditation program ensures that organizations providing validation and verification services meet rigorous standards set by ISO/IEC 17029, ISO 14065, ISO 14066, and ISO 14064-3. These standards cover various aspects, including competence requirements for validation and verification teams, principles for validating and verifying environmental information, and specifications for the verification and validation of greenhouse gas statements.

By engaging with accredited verification bodies like those accredited by ANAB, companies subject to the SEC rule can demonstrate their commitment to transparency and accuracy in emissions reporting. Independent third-party verification not only enhances data reliability but also provides stakeholders with necessary assurances that reported emissions are calculated and reported accurately

Source: https://blog.ansi.org/anab/verification-bodies-sec-rule-ghg-disclosures/

National Minimum Standards and Protocol for Creche

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National Minimum Standards and Protocol for Creche

The Ministry of Women and Child Development has released the “National Minimum Standards and Protocol for Creche” (Operations & Management) in order to ensure that standardised and quality creche services are available in all establishments across the Country. This will provide necessary guidance for setting up of Creches across the country.

These standards and protocol aim to provide comprehensive childcare in a safe and secure environment, fostering the overall development of children.

State Governments and UT Administrations are also advised to adopt these standards and protocol for setting up and management of creches.

Click here to read the Minimum Standard & Protocol

Source: https://wcd.nic.in/acts/national-minimum-standards-and-protocol-cr%C3%A8ches-operation-and-management

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