Healthcare Regulatory Compliances & Standards

Ensuring compliance is a seamless experience when partnering with EMed HealthTech. Our expert team
develops healthcare software and app that adhere to all applicable regulations.

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Regulatory & Security
Compliances in Healthcare

In healthcare, regulatory compliance refers to all stakeholders adhering to industry regulations and laws, including providers, payers, vendors, and not-for-profits. In healthcare, regulations mandate strict rules to ensure data privacy, patient safety, and quality of care. Healthcare compliance encompasses a wide range of practices and observes both internal and external regulations. Both small hospitals and major healthcare providers are subject to regulatory requirements.

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Regulatory & Security Compliances in Healthcare
Regulatory & Security Compliances in Healthcare
Regulatory & Security Compliances in Healthcare

Why is Healthcare Regulatory Compliance Required?

Healthcare Regulatory Compliance is crucial for maintaining smooth operations and ensuring adherence to legitimate
procedures while promoting a clear understanding of expectations.

Legal and Ethical Obligations

Laws and regulations are in place to ensure that healthcare providers maintain a high standard of care, protect patient privacy, prevent fraudulent activities, and avoid legal penalties & fines for non-compliance.

Data Security and Privacy

With the digitization of healthcare information, compliance regulations help protect patient data from unauthorized access, breaches, and misuse. Compliance requirements, help establish protocols for the secure handling, storage, and transmission of sensitive patient information.

Patient Safety

Healthcare regulatory compliance ensures that healthcare providers adhere to specific standards and guidelines designed to minimize the risk of harm to patients and provide a safe environment for care in terms of medication safety, infection control, patient privacy, and medical device safety.

Quality of Care

By adhering to healthcare standards, healthcare providers promote the delivery of high-quality healthcare services in terms of improving patient outcomes, enhancing care coordination, and ensuring consistent & effective care.

Industry Standards and Best Practices

Industry standards are developed based on evidence-based research and expert recommendations. By complying with these standards, organizations can improve their operational efficiency, adopt proven methodologies, and implement effective strategies for patient care.

Reimbursement and Insurance Coverage

It is necessary for healthcare organizations to receive reimbursement for services provided to patients. Government-funded healthcare programs, private insurers, and other payers may require compliance with specific standards before authorizing payment for services rendered.

Healthcare Regulatory Compliances Country Wise

Every country has certain healthcare regulations to follow while developing healthcare software solutions.
Some of the major healthcare regulations are given below:

HIPAA - Health Insurance Portability and Accountability Act: USA

HIPAA is a U.S. federal law enacted in 1996 to protect sensitive patient health information from unauthorized disclosure. It establishes national standards for electronic healthcare transactions and ensures the security and privacy of health data. HIPAA compliance is crucial for healthcare providers, health plans, healthcare clearinghouses, and their business associates to protect the confidentiality, integrity, and availability of protected health information (PHI).

Protects patient privacy and secures healthcare information

Regulates the handling and sharing of sensitive healthcare records

Ensures the confidentiality, integrity, and security of electronic health information (ePHI)

Establishes safeguards for secure transmission and storage of health data

Ensures compliance through workforce training and breach notification requirements

IHE - Integrating the Healthcare Enterprise: Global

IHE - Integrating the Healthcare Enterprise: Global

IHE is an initiative designed to enhance the communication and exchange of data between healthcare systems. By bringing together healthcare professionals, vendors, and standardization organizations, IHE creates guidelines to ensure seamless interoperability across various healthcare systems.

To ensure interoperability between different healthcare systems

Provides standardized profiles based on established frameworks like HL7 and DICOM

Aims to improve patient care through better data exchange, reducing errors, and supporting informed decision-making

Focuses on data security and privacy to ensure compliance with regulations like HIPAA

GDPR - General Data Protection Regulation: Europe

GDPR is a comprehensive data protection law that applies to European countries. Healthcare providers must ensure that they comply with the requirements of public authorities and demonstrate that they are adequately protecting patient information.

It establishes strict rules for processing, storing, and transferring personal data

Handling patient data with care and meeting regulatory requirements

Ensuring the secure handling of patient data

Prioritizes data privacy, transparency, and individual rights

PIPEDA - Personal Information Protection and Electronic Documents Act: Canada

PIPEDA is a privacy law in Canada that sets the ground rules for how private-sector organizations collect, use, and disclose personal information in the course of for-profit, commercial activities across Canada.

Set rules for the collection, use, and disclosure of personal information

Ensuring that patient data is handled with care and under Canadian privacy laws

Secure environment for Healthcare data, maintain confidentiality, protect the privacy rights

Personal information must be protected by appropriate security measures

DPDP Act - Digital Personal Data Protection Act: India

The Digital Personal Data Protection (DPDP) Act is an Indian law enacted to regulate the processing of personal data while ensuring privacy and security. It establishes guidelines for collecting, storing, and sharing personal data, including health information, to protect individuals' rights and promote responsible data governance.

Protects individuals' personal and health data from unauthorized access and misuse

Regulates the collection, processing, and sharing of digital personal data

Ensures data confidentiality, integrity, and security through compliance measures

Provides individuals with rights over their data, including access, correction, and consent management

Mandates secure storage and transmission of sensitive data

Enhances trust in digital healthcare services by ensuring data protection

ABDM- Ayushman Bharat Digital Mission: India

ABDM is an initiative by the Government of India aimed at building a comprehensive digital healthcare ecosystem to ensure accessible, affordable, and efficient healthcare services for all citizens. The mission focuses on the secure management and exchange of health data across healthcare providers and patients.

Manages secure exchange of health records between providers and patients

Creates a network of digital health service providers, enabling interoperability

Ensures the secure storage and sharing of health records across healthcare systems

Prioritizes data privacy through user consent-based access to medical records

HL7 & FHIR: International

HL7® FHIR®: International

FHIR (Fast Healthcare Interoperability Resources) is an interoperability standard developed by HL7 (the Health Level 7 standards organization) designed to enable the exchange of healthcare data electronically between different systems in the healthcare industry.

Exchange of health information between different systems and organizations

The HL7 FHIR is committed to respecting the privacy of its members and visitors

Improved coordination and collaboration in healthcare delivery

Works across various countries and healthcare settings

DICOM - Digital Imaging and Communications in Medicine: Global

DICOM - Digital Imaging and Communications in Medicine: Global

DICOM is an international standard for managing, storing, transmitting, and sharing medical imaging information. It plays a crucial role in ensuring the interoperability of imaging devices and systems, ensuring secure and efficient communication of medical images across healthcare providers.

Facilitates secure exchange of medical imaging data between devices and systems

Ensures the confidentiality, integrity, and security of patient imaging records

Supports interoperability across different imaging devices and healthcare systems

Provides standardization for storing and sharing medical images, including X-rays, MRIs, and CT scans

Protects patient privacy through secure transmission and data access control mechanisms

How EMed HealthTech Can Help to Implement Healthcare Regulatory Compliance

How EMed HealthTech Can Help to Implement Healthcare Regulatory Compliance?

We at EMed HealthTech, follow a secure software development lifecycle and provide the best custom healthcare software development services and solutions with all the necessary healthcare regulatory compliances.

Develop a Security Management Process

Implement Technical Safeguards

Implement Physical Safeguard

Develop and Implement Policies and Procedures

Provide Training for Regulatory Compliance

Ensure Business Associate Compliance

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