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Statutory Compliance Services that Help Healthcare Leaders Keep Their Heads Above Water

 

 

What is Healthcare Compliance?

 

Compliance is a critically important aspect of healthcare. Healthcare device and tech manufacturers are required to comply with a daunting magnitude of national and international rules, regulations, and legislation today. The idea is to set up a business process that sustainably stays updated on the most recent compliance needs and follows them closely. One way to ensure that your business stays on top of things with its compliance programs is through compliance consulting firms whose core activities revolve around healthcare regulations and legalities. It keeps you updated about recent legal updates, saves you time & internal training costs, and eliminates the possibility of unnecessary regulatory hiccups. 



 

Differentiating Statutory Compliance and Regulatory Compliance

 

As a beginner in the healthcare business, legal terms can be confusing. As healthcare practitioners-turned-entrepreneurs, we have made a run at explaining the healthcare legal lexicon better.



What is statutory healthcare compliance?

 

Statutory compliance is a set of requirements that businesses must adhere to by law. Statutory compliance is a type of compliance stated by ‘statute’- a written law already passed by a legislative body. If you fail to comply, it will result in hefty fines, legal actions, and damage to the brand. 

 

Statutory compliance is related to healthcare services, devices, its safety, data protection, environmental regulations, and employment laws. The examples of statutory compliance laws are named after their related sectors & functions.

 

Regulatory compliance, on the other hand, is a set of requirements compiled by industry leaders and bodies; businesses in that industry must follow the law. Hence, they are industry-specific and will lead to fines, legal actions, and revoke of licenses if ignored. 

 

Hence, the National Accreditation Board for Hospitals and Healthcare Providers (NABH) standards, the Drugs and Cosmetics Act, the Clinical Establishments (Registration and Regulation) Act, and the Indian Medical Council Act are specific to the healthcare industry, but the Bonus & Gratuity Act can be applied to most sectors.

 

A list of statutory & regulatory compliance laws (a few examples) in Indian healthcare includes:

 

Laws related to governing the Hospital

Society registration act

Companies Act

Clinical Establishments Bill

Fire Safety Rules

 

Laws Governing the Qualifications / Practice and Conduct of Professionals

Indian Medical Council Act

Indian Nursing Council Act

The Dentists Act

 

Law Governing Storage / Sale of Drugs and Safe Medication

Drugs and Cosmetics Act

VAT Act

Pharmacy Act

Blood bank regulations under Drugs and Cosmetics rules

 

Law Governing Biomedical Research

Breeding and Experiments on Animals Amendment Rules

 

Law Governing Medico-Legal Aspects

Consumer Protection Act

Protection of Human Rights Act

IPC section 52

 

Law Governing the Safety of Patients, Public, and Staff within the Hospital Premises and Environmental Protection

Indian Boilers Act

Gas Cylinder Rules

Arms Act

Vaccination Act

 

Laws Governing the Employment of Manpower

Child Labour Act

Bonus & Gratuity Act

ESI Acts, Rules

Industrial Disputes Act





 

Why is Compliance Important in Healthcare?

 

Statutory and regulatory compliance is universally critical for ethical & efficient business operations. It has become an inch more vital in healthcare owing to its impact on lives. If we were to discuss the top five reasons why compliance should be on your priority list when establishing your business operations, here’s what we would say:

 

 

  • Ensures top-tier services and products in your healthcare niche

Compliance promises patient safety and quality of care by following set guidelines and norms of patient care and procedures in the industry. So your product, service, or device soon holds top positions in the industry. They are considered verified, safe, and the latest. 

 

  • Maintains smooth, hassle-free, and industry focussed business operations

Compliance negates legal risks, protecting your firm, service, or product from fines, lawsuits, and reputational damage. Furthermore, it encourages ethical behavior and integrity fostering trust between patients, providers, and regulatory bodies.

 

  • Boost conversion rates

Patients, vendors and all the key stakeholders are more likely to approach healthcare providers and products that have been cleared under compliance and ethical regulations.

 

  • Attracts investors

Compliance is an essential factor for venture capitalists and angel investors when assessing funding prospects in the healthcare sector, as it shows operational maturity and risk management.

 

  • It adds credibility to your vision and mission

A compliant healthcare provider soon gains trust, fame and interest in the industry. It is the best way to vet your mission, vision, and business objectives. 




 

What are Compliance Issues in Healthcare?

 

The pandemic has severely disrupted the healthcare ecosystem. It provoked many changes in healthcare delivery and use. Keeping up with each of these compliance regulations is challenging, time-consuming and costly. 



A few compliance issues in healthcare include:



  • More scrutiny from the regulatory heads than ever before

In the wake of events such as telehealth, electronic health records (EHRs), cloud storage and online collaborations, misappropriated medical relief funds, and several medical data breaches, the Digital Personal Information Privacy Act, 2023 has renewed its focus on healthcare regulations more today than ever before.

 

  • Data protection and Cybersecurity

Access, use, and retrieval of EHRs are severely monitored, encrypted, and responsibly handled worldwide. Ransomware attacks in healthcare have doubled in the past five years, leading to 20 days of increased downtime, impacting clinical operations and patient care. The average cost of a healthcare ransomware attack in 2021 was $4.82 million. Telehealth technology vulnerabilities have also risen, posing risks to patient information.



  • Exploring the use of private data in healthcare advertising

The surge in targeted & personalized advertising has flooded healthcare too. You may have searched for ‘diabetes doctors near me’ a week ago, and now all your social media channels show you products, devices, and services related to diabetes. That is the specificity of targeted healthcare advertising. 

 

Another important aspect is the use of patient data and case profiles for personal advertisements by healthcare practitioners and firms. While it is perfect to showcase your expertise with consent, it is imperative to understand ‘how much’ of patient data should go in for public view. 

 

In India, data protection laws currently lack specific restrictions on using personal data for direct marketing, allowing advertisers to leverage databases freely. While the SPDI Rules require businesses to disclose data processing activities in privacy policies, they often lack clarity. 

 

Consumer protection and antitrust regulations address lawful advertising but not privacy protection. Consent under SPDI rules (Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information Rules, 2011) is easily obtained through complex privacy policies, with low thresholds for compliance. 

 

The Digital Personal Data Protection Act, 2023 (DPDPA), addresses profiling but remains in development, leaving many operational and compliance requirements uncertain, particularly concerning privacy and personalized advertising.



  • Third-party Risk Management

Healthcare faces rising third-party risks due to over 1,300 vendors, with 72% having high access. Hackers target them, using cloud ransomware. The regulatory focus intensifies, but tracking is weak. Rehabilitation is rare; just 30% take action. The inability to verify control efficacy undermines risk management's efficiency.

 

 

 

A List of Statutory Compliance Services the Healthcare Industry Needs

 

Compliance is an ongoing process. It needs continuous education, adaptability, and a persistent desire to sustain standards of patient care and ethical conduct, and it is best achievable through a Statutory Compliance Consultant in the healthcare industry.

 

Here are the top 3 Roles and Responsibilities of Statutory Compliance Consultants in the Healthcare Industry

 

  • Stay up-to-date with the latest compliance regulations in he healthcare industry

 

  • Conduct a compliance gap analysis and develop plan & policies to best suit the healthcare provider and its compliance needs

 

  • Ensure streamlined privacy, data security, documentation and record keeping



 

 

Statutory Compliance Consultants Onboard the Anastomos Marketplace

 

In a world full of shortcuts and quick fixes, compliance is a long road to success. Healthcare as an industry dealing with lives underlines the importance of compliance further. The Anastomos Marketplace is a repository of the finest vendors in healthcare, including the best statutory compliance consultants. We have onboard, with us, IMAGE CARE.

 

As certified assessors for NABH-MIS (Radiology) and radiation safety professionals accredited by AERB, they offer comprehensive services tailored for the Medical Imaging & Radiology sector. Their services also include department planning and commissioning, conducting pre and post-audits for NABH (Radiology), ensuring compliance with statutory requirements such as AERB (eLORA) and PC&PNDT, teleradiology solutions, as well as sales, servicing, and quality assurance for radiology equipment.

 

Are you and your team struggling to establish a compliance team? Then, sign up in our Marketplace and let us take it from there.