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Healthcare software must comply with strict regulations to ensure data security, patient privacy, and legal compliance. HIPAA (Health Insurance Portability and Accountability Act) in the U.S. mandates secure handling of patient data, requiring encryption, access controls, and breach notifications. GDPR (General Data Protection Regulation) in the EU focuses on patient consent, data portability, and the right to be forgotten.

Other critical compliance issues include FDA regulations for medical device software, HITECH Act for electronic health records (EHRs), and ISO 13485 for quality management in medical software. Ensuring interoperability with standards like HL7 and FHIR is also essential.

Failure to comply can result in legal penalties and loss of trust. Developers must integrate robust security measures and follow industry standards. For a deeper understanding of these compliance challenges, businesses can refer to a healthcare software development guide to ensure regulatory adherence.