The healthcare tech landscape is evolving rapidly, and various regulations are continually being developed and existing ones refined to ensure that technology is developed according to standards and is implemented ethically.
As innovations such as healthcare information management systems, data modernization techniques, electronic health record (EHR) systems, and AI-driven diagnostics become part of modern healthcare practice, robust regulatory frameworks have become all the more important. This guide explores the key regulations and standards that govern healthcare technology.
Understanding Healthcare IT Standards and Regulations
Healthcare IT standards are important as they ensure that there’s a seamless exchange of communication between the different systems and their applications. These standards help maintain the interoperability of the systems and the security of healthcare information.
Without adequate and right standards, sharing patient data, including medical records, across platforms can prove to be arduous and may even lead to compromise in patient data safety, identity, and quality of care that is being delivered.
A Look at the Major Healthcare IT Standards
1. HIPAA (Health Insurance Portability and Accountability Act)
HIPAA came introduced in 1996, and is considered as one of the important legislations that governs healthcare data in the United States. It covers various aspects of personal health information (PHI). The breakdown of the key rules in HIPAA are as follows:
- Privacy Rule: The privacy rule consists of information on how PHI should be used and disclosed. It states that healthcare organizations should obtain patients’ consent before using and sharing their personal information for processes that are not treatment related.
- Security Rule: This outlines the various standards that should be adhered to when sharing or accessing patient data through electronic PHI (ePHI). This includes various safeguards such as administrative, physical, and technical and emphasizes data encryption, implementing access controls, and maintaining audit logs.
- Breach Notification Rule: This rule necessitates that all organizations should notify patients and the Department of Health and Human Services (HHS) of any PHI breaches. If breach has affected over 500 individuals, the media should also be notified.
2. HITECH (Health Information Technology for Economic and Clinical Health Act)
HITECH was passed in 2009, and it promotes the adoption and use of health information technology. It enforces stricter compliance requirements and provides financial incentives to implement electronic health records (EHRs). HITECH also has measures to implement HIPAA enforcement and penalties for non-compliance.
3. GDPR (General Data Protection Regulation)
The GDPR came into effect from May 2018. It regulates data protection across the European Union (EU) and even applies to organizations that operate from outside the EU but handle data of EU residents. It necessitates organizations to implement robust measures to protect personal data of the EU residents. In the event of any data breaches, organizations are required to notify within 72 hours, and appoint a Data Protection Officer (DPO).
4. FDA (Food and Drug Administration) Regulations
The FDA is responsible for overseeing the regulation of healthcare information management, medical devices and software that are intended to perform the medical functions. Depending on the risk associated with a device or software, it may fall under Class I (low risk), Class II (moderate risk), or Class III (high risk). While each category has a set of rules that organizations need to follow, Class I devices generally require less regulatory oversight, while Class III devices need premarket approval due to their higher risk.
5. HL7 (Health Level Seven)
HL7 charts out rules that apply to the integration, sharing, and retrieval of healthcare information. Versions 2 and 3 of HL7 are used in various healthcare organizations.
6. FHIR (Fast Healthcare Interoperability Resources)
FHIR is built on HL7 standards and offers a modern approach to exchanging data.. It allows the sharing of healthcare data in a more accessible format across different platforms and systems.
7. DICOM (Digital Imaging and Communications in Medicine)
This rule aims to standardize the communication and management of medical imaging data. It includes metadata about the patient and imaging process to ensure compatibility across various imaging devices and systems.
The Need for Maintaining Compliance for Healthcare Technology Providers
1. Product Development and Design
Understanding regulatory requirements right from the beginning of the development process is crucial for healthcare organizations. Technology providers should be well-versed in the specific standards that are applicable to their products. This involves thoroughly documenting the development process (a standard operating procedure can prove useful here) and aligning it with regulatory expectations.
2. Premarket Requirements
Before launching a healthcare technology product, healthcare teams must meet various premarket requirements. This includes preparing and submitting detailed documentation about the product to relevant regulatory bodies. For instance, FDA approval may be required for certain medical devices.
3. External Compliance Testing
Engaging third-party auditors to conduct compliance testing can help organizations to identify potential issues and take steps to rectify before the market entry. These audits will help ensure that the product meets regulatory standards and reduces the risk associated with non-compliance. You can also recruit registered health information administrators (RHIA) certified individuals as they are expert in managing PIH and in compliance regulations.
4. Post-market Compliance
Once the product has been launched and is available for sale in the market, post-market compliance takes place. is essential. This includes conducting internal and external audits on a regular basis, updating compliance procedures, and training employees to adhere to regulatory requirements.
Considerations for Healthcare Organizations
Healthcare organizations should have a compliance program that adheres to regulatory standards. This involves creating a compliance committee, appointing a Chief Compliance Officer (CCO), and developing detailed policies and procedures.
The team should carry out regular audits for maintaining compliance. Third-party auditors can be engaged to check if the compliance practices are being allowed and identify areas for improvement.
A robust employee training program is important to ensure that the entire staff understand and comply with regulatory requirements. Continuous education helps keep employees informed about changes in regulations and best practices.
The Future of Healthcare Tech Regulations
As healthcare technology continues to advance, there will be new challenges and hence regulatory standards will evolve too. Emerging technologies such as artificial intelligence (AI), Clinical Information System (CIS) and the Internet of Medical Things (IoMT) will add to the existing regulations and the development of new ones.
Staying informed about healthcare tech regulations is crucial for both technology providers and healthcare organizations. It will also help them engage with regulatory experts and industry groups and wade through the complex healthcare landscape efficiently and ensure compliance.
To conclude, healthcare tech regulations are important as they ensure the safety, security, and effectiveness of healthcare technologies and protect patient data. By understanding and adhering to key standards and regulations, technology providers and healthcare organizations can offer better patient care and contribute to a more secure and efficient healthcare system.