Key Laws for Medical Software Development - Blog

Building Healthcare Applications: Key Laws for Medical Software Development

Key Laws for Medical Software Development

Healthcare apps have huge potential to improve patient outcomes and experiences. But before get one, it’s important to understand the key laws for medical software development. Healthcare app owners have serious responsibilities to users and their sensitive health data. Non-compliance can put patients at risk and invite major legal trouble.

Don’t let that scare you away though. With the right knowledge and precautions taken early on, you can build an app that is both innovative and compliant. In this article, we’ll walk through the key healthcare regulations and standards you must know. We’ll break down what exactly is required and provide tips for staying on the right side of the rules.

The Significance of HIPAA Compliance for Healthcare Application Development Providers

HIPAA, short for the Health Insurance Portability and Accountability Act, establishes guidelines for safeguarding individuals’ private health information. For app developers, not complying with HIPAA regulations can result in significant penalties and harm your professional standing.

To ensure your app is HIPAA-compliant:

  • Conduct a risk analysis to identify any vulnerabilities in your system that could compromise patient data.
  • Encrypt any personal health information stored on your servers or transmitted between your app and servers.
  • Limit access to PHI. Only allow authorized users to access, use, and disclose personal health information. Implement strict login processes for users and track who accesses what data.
  • Provide patients control over their data. Empower them to access their health information, make corrections, request restrictions on disclosures, and easily revoke access to their data whenever they choose.
  • Ensure proper training. Anyone who interacts with patient data must have appropriate HIPAA training to understand their responsibilities. This includes developers, healthcare providers, support staff, and anyone else with access.
  • Have a contingency plan. Establish procedures to identify, respond to, and mitigate breaches of unsecured personal health information. This could include notifying patients and authorities if a data breach occurs.

By making HIPAA compliance a priority in your healthcare app development process, you’ll build app patients and providers can trust. The time you put in upfront will give you peace of mind that you’re protecting people’s most sensitive data.

Key Laws for Medical Software Development

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The Role of FHIR and HL7 Data Exchange Standards in Building Healthcare Applications

FHIR and HL7 are two of the important standards and regulations guiding the healthcare industry. They establish how health data should be exchanged and shared.

FHIR (Fast Healthcare Interoperability Resources) is the latest standard created by HL7, an international health informatics organization. FHIR makes it easier for healthcare systems and applications to share data by providing a standardized way to format it.

  • FHIR resources represent granular clinical concepts like patients, practitioners, medications, etc. These resources can be combined to share complex health records.
  • FHIR uses web standards like JSON and XML, so it’s easy for developers to work with.
  • FHIR enables seamless data sharing across institutions, platforms, and applications. This helps provide patients with a complete view of their health data.

HL7 refers to a broader set of standards, including FHIR, focused on the exchange, integration, sharing, and retrieval of electronic health information. HL7 standards aim to ensure the meaning, context, and detail of health data transfers are preserved.

By adopting HL7 and FHIR standards, healthcare organizations and technology companies enable more efficient, accurate, and secure data sharing. Patients benefit from improved care coordination and access to their records. Developers gain a framework for building interoperable solutions. And the healthcare system achieves greater productivity, reduced costs, and better outcomes overall.

Emerging Data Standards in Healthcare: ICD-10, XDS/XDS-I, and EVV

Along with the key laws for medical software development in USA, there are several emerging data standards as well. Compliance with these ensures that your healthcare apps are future-ready for any regulatory changes.


The ICD-10 is a global health data standard for recording and reporting various aspects of diseases, including their causes, symptoms, and social circumstances. Software must be able to generate, store, process, and report this data

  • ICD-10 includes approximately 70,000 codes, compared to about 14,000 codes in the prior version (ICD-9). This provides more detailed information about patients’ medical conditions and treatment procedures.
  • ICD-10 allows for greater specificity in describing diseases, injuries, and procedures. It improves accuracy in identifying health trends, public health issues, and healthcare costs.
  • ICD-10 codes are required for medical claims, public health reporting, and other healthcare data analysis.


Cross-Enterprise Document Sharing (XDS) and XDS for Imaging (XDS-I) are standards developed to enable the sharing of electronic health records between healthcare organizations.

  • XDS defines how to share documents like discharge summaries, imaging reports, and lab results across healthcare enterprises.
  • XDS-I extends XDS to share medical images. By using a standardized format to share images and associated data, physicians have immediate access to prior exams and reports, even if they were performed at another facility.
  • To build applications supporting these standards, you must understand specifications like ebXML, ebRIM, and DICOM.

Electronic Visit Verification (EVV)

EVV systems use technology like interactive voice response, telephones, and mobile devices to electronically verify home or community-based visits.

A medical billing software must with EVV regulations and standards. EVV helps ensure accurate reporting and verification of services delivered. It also prevents fraud by confirming the caregiver’s identity, the recipient, the date/time of service, and the type of service provided.

The Impact of Data Standards on Healthcare Interoperability

Data standards in healthcare aim to improve interoperability between systems and enhance the exchange of health information. When systems can “talk” to each other, providers have a more complete view of a patient’s health history and conditions, leading to better care coordination and outcomes.

Interoperability through Standards

Several standards have been developed to enable seamless data exchange in healthcare. Some of the major standards include:

  • HL7 (Health Level Seven International): Focuses on the exchange, integration, sharing, and retrieval of electronic health information. HL7 standards are the most widely used in healthcare IT.
  • FHIR (Fast Healthcare Interoperability Resources): Built on HL7 standards, FHIR aims to facilitate health information exchange through an easy-to-implement set of standards. FHIR allows systems to quickly and efficiently share data.
  • DICOM (Digital Imaging and Communications in Medicine): The global standard for transmitting, storing, retrieving, printing, and displaying medical imaging information. DICOM enables the integration of medical imaging devices and workstations.
  • LOINC (Logical Observation Identifiers Names and Codes): Provides universal codes and names for laboratory tests and other health measurements. LOINC enables the exchange and pooling of results for clinical care, outcomes management, and research.

Driving Efficiency and Improved Care

When healthcare organizations adopt interoperability standards, the benefits are substantial. Providers can access comprehensive patient health data to make the best treatment decisions. Patients receive higher quality, better-coordinated care with fewer errors and duplicated tests. Healthcare systems become more efficient, reducing costs through decreased paperwork, improved care transitions, and the automation of manual processes.

Interoperability powered by standards is transforming healthcare for the better. Although adoption is still ongoing, the future is bright for a fully connected healthcare ecosystem centered around the patient.

Read Also: Why You Need Mobile Healthcare Apps For Your Healthcare Business

Implementing Data Standards in Healthcare Applications

To build effective healthcare applications, you need to understand and implement key data standards. These standards enable seamless data sharing across systems and platforms. 

Integrating HL7 Standards

The Health Level Seven International (HL7) organization publishes standards for exchanging, integrating, sharing, and retrieving electronic health information. HL7’s Fast Healthcare Interoperability Resources (FHIR) standard defines data elements and an API for exchanging healthcare information electronically.

Integrating FHIR

When building healthcare software, integrating the FHIR standard allows you to:

  • Share patient data between providers, payers, and patients
  • Enable third-party app integration
  • Reduce redundant data entry
  • Improve care coordination and patient outcomes

To use FHIR, you’ll need to:

  1. Choose which FHIR resources, like Patient or Observation, you want to implement based on your app’s needs.
  2. Expose an FHIR API endpoint in your app that allows Create, Read, Update, and Delete (CRUD) operations on resources.
  3. Validate request and response data against the FHIR specification.
  4. Consider security standards like OAuth2 to authorize access to patient data.

Other standards

There are additional standards to consider:

  • ICD: The International Classification of Diseases defines diagnosis codes.
  • SNOMED CT: A comprehensive clinical terminology used in EHRs.
  • LOINC: The Logical Observation Identifiers Names and Codes standard provides universal codes for laboratory and clinical observations.
  • RxNorm: Normalizes medication names and dose forms across systems.

Implementing data standards in your healthcare applications will make data more portable and interoperable, allowing for improved care and outcomes. Staying up to date with new releases of standards is key to building innovative, patient-centered software.

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Building a healthcare app may come with more red tape, but the rewards of improving people’s lives are worth it. It’s critical to comprehend privacy regulations and key standards around data exchange to properly handle and safeguard patients’ protected health information. 

If you need a reliable health tech partner who can follow the laws for medical software development and provide a compliance-ready end product, get in touch with us. Here’s why you should consider DreamSoft4u’s healthcare software development services:

  1. Deep Understanding of Healthcare Regulations: Our team is well-versed in the laws, standards, and requirements that govern the healthcare industry. We ensure that patient data is safeguarded throughout the development process.
  2. HIPAA-Compliant Solutions: With VCDoctor, your healthcare application will meet the stringent requirements set by HIPAA. We implement robust data encryption, empower patients with data control, and establish contingency plans for breach mitigation.
  3. Expertise in FHIR and HL7: We have worked with  FHIR and HL7 standards, and built applications that facilitate the exchange of health data across systems and platforms.
  4. Knowledge of Emerging Standards: We stay updated on emerging data standards such as ICD-10, XDS/XDS-I, and EVV. We incorporate these standards into your software solutions, ensuring compliance and secure electronic health record sharing.
  5. Commitment to Quality and Innovation: We are fully dedicated to building solutions that improve patient outcomes, enhance care coordination, lower costs, and streamline healthcare processes.

With DreamSoft4u by your side, your software solutions will not only meet the necessary compliance standards but also contribute to the improvement of patient outcomes and experiences.

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Sanjeev Agrawal

Sanjeev Agrawal

My name is Sanjeev Agrawal. I am a Director and Co-founder of Dreamsoft4u, IT Consulting Company. I am having a keen interest in the latest trends and technologies that are emerging in different domains. Being an entrepreneur in the field of the IT sector, it becomes my responsibility to aid my audience with the knowledge of the latest trends in the market.