The Security Rule sets forth standards to protect ePHI that is created, received, used, or maintained by a covered entity. The rule also gives patients certain rights over their health information, including the rights to view, obtain a copy, and request corrections of their records. The rule is meant to facilitate the flow of health data in a way that limits fraud and theft. The Privacy Rule standards were designed to protect the use and disclosure of medical records and other PHI. HIPAA defines 5 major rules that all healthcare software applications must follow: 1. Generally speaking, HIPAA is both strict (with many rules and severe penalties) and vague (with liberty on how best to apply the rules). HIPAA compliance involves meeting the requirements of HIPAA and its related rules, amendments, and related legislation. What are the Requirements of HIPAA Compliance? Personal health or mental health tracking.Examples of mHealth apps that may be excluded from HIPAA include: The OCR stated that HIPAA is limited in the regulation of third-party health apps that are chosen by and used by patients and are not connected to or used by physicians – unless the app developer is a covered entity or business associate. With the growth of the mobile marketplace and the number of wearable tracking devices, we are seeing a boom in the use of mHealth apps – but not all of these apps need to be HIPAA compliant. It is important for healthcare software developers to be aware of what HIPAA will require of the app in terms of security controls as well as certain workflows such as PHI removal (continue reading for more). Patient monitoring apps or medication compliance apps, if connected with physicians.Healthcare apps that collect data for, or communicate with, healthcare providers. Telemedicine or secure / private messaging apps.Protected health information (PHI) and electronically protected health information (ePHI) refer to any identifiable data about the patient, including name, address, date of birth, SSN, device identifiers, email addresses, biometric, lab or imaging results, medical history, and payment information.Įxamples of healthcare and mHealth apps that need to be HIPAA compliant are: Healthcare apps that plan to store, record, or share PHI will be subject to HIPAA rules during their use. What type of data will the application use, share, or store? With HIPAA, the onus for compliance falls with the covered entity (healthcare provider, health plan, healthcare clearinghouse) or business associate (any associate who has access to PHI). What type of entity will use the application? The important questions to answer about whether or not your mHealth app or healthcare software needs to be HIPAA compliant are: If you are planning to develop healthcare software or a mobile healthcare app, particular attention must be paid to HIPAA. Which Healthcare Apps Should Comply With HIPAA Rules? This guide will provide a general introduction to HIPAA and how to develop HIPAA-compliant software. HIPAA is just one of many data protection laws in the US. The Healthcare Insurance Portability and Accountability Act (HIPAA) of 1996 is a Federal law that requires covered entities and business associates to self-regulate their security practices to be compliant with specific standards. If you are looking to build a healthcare app that will interact with electronic protected health information (ePHI), like a hospital or healthcare startup, HIPAA will be on your radar. Propelled in part by the COVID-19 pandemic, significant growth will be seen in areas such as telemedicine, augmented and virtual reality, artificial intelligence, wearable technology, and the Internet of Medical Things – all areas poised to either improve patient health, aid in medical discoveries, or reduce healthcare costs. For the mobile health (mHealth) marketplace, Gartner estimates growth at 43.9% CAGR by 2027. The global healthcare software market is growing at a 13% CAGR, estimated to reach USD 76.45 billion by the year 2025.
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