What Are Covered Entities Under HIPAA?

What Are Covered Entities Under HIPAA?
HIPAA compliant Application

The HIPAA Covered Entities Guide

The expansion of mobile computing and electronic transaction processing in the healthcare industry has created an enormous opportunity to improve health outcomes, while at the same time reducing costs. To take advantage of this opportunity, those entities dealing with sensitive information or with some degree of influence on healthcare decisions (“covered entities”) must comply with a variety of privacy and security regulations.
The U.S. Department of Health and Human Services, in coordination with other federal agencies, has created a set of regulations that govern the use and protection of privacy and security information under the HIPAA (Health Information Portability and Accountability Act) Security Rule. The Security Rule is important because it provides guidance to covered entities on how they should handle PHI (Protected Health Information).
Today, we’re going to talk about what HIPAA means by “covered entities”. Then we’re going to take a look at the types of covered entities.

What are Covered Entities?

The HIPAA Security Rule defines covered entities as follows:
A covered entity is any person who creates, receives, maintains or transmits health information in electronic form in connection with a transaction. A covered entity may be an individual, such as a physician or other healthcare provider, who transmits protected health information for treatment purposes.
But what does it mean to be a “person” in this context? The Security Rule is pretty clear on this point. As long as the covered entity meets one of the following criteria, that person is not a covered entity:
  • A government agency.
  • Some types of business entities that do not create, receive, maintain or transmit PHI is defined as “business associates.” A business associate is generally defined by what they do for the covered entity: being hired to perform certain functions and provide certain services.
The following types of entities are not covered entities:
  • An individual who is a member of the immediate family of a covered entity and who receives protected health information from a covered entity only for the individual’s own health care or remits such information to a third party for the individual’s own health care;
  • State or local government agencies that do not maintain PHI in electronic form; and
  • Health plan enrollees who do not have access to electronically protected health information.

Types of Entities Covered Under HIPAA

HIPAA Compliance App Development Company
The HIPAA Security Rule defines three types of covered entities: “covered health care provider”, “health plan” and “health care clearinghouse.” Today, we’re going to talk about what the Security Rule has to say about covered health care providers.

Covered Health Care Provider

Covered healthcare providers are those organizations (e.g., healthcare providers, physicians, etc.) that transmit PHI electronically in connection with a transaction. For example, a covered healthcare provider may transmit data to a pharmacy benefits manager in connection with the processing of a prescription.
Not all healthcare providers have covered entities under HIPAA. Only those organizations that create, receive, maintain or transmit PHI electronically in connection with a transaction are covered entities.

Health Plans

Health plans are those organizations that offer or administer health benefit plans. The Security Rule does not differentiate between different types of health plans (e.g., insured or self-funded). All health plans are covered entities regardless of whether they are a PPO, HMO, Medicare or Medicaid plan.
For example, a plan administrator that runs a Medicare Part D prescription drug plan for certain covered employees would be a covered health plan. Conversely, an individual enrolled in a Medicare HMO who uses an independent contractor pharmacy where the pharmacist is paid a salary rather than an hourly wage would not be considered a covered health care provider because the individual is not involved in the creation of, the transmission of or use for treatment purposes of PHI.

Healthcare Clearinghouses

Healthcare clearinghouses provide medical data to other healthcare providers for the purpose of verifying the eligibility for or enrollment in a health plan. The Security Rule does not require covered entities to use a particular entity as a clearinghouse. It simply requires that there be a mechanism by which protected health information is transmitted between healthcare providers.

What is a Business Associate?

A business associate is a person or organization (e.g., pharmacy benefits manager) that performs certain functions or activities on behalf of a covered entity and uses or discloses protected health information in connection with its performance of the function.
A business associate is not subject to all the requirements of the HIPAA Security Rule but he must comply with all applicable “minimum necessary” requirements. For example, if a pharmacy benefits manager performs services for a physician to help the physician bill insurance companies, it would be considered a business associate.

Wrapping Up

The HIPAA Security Rule is a complex set of guidelines that is constantly evolving as new technologies emerge. This post was a very brief summary of what the rule says about covered entities. If you want to learn more about HIPAA violations and cloud computing in healthcare, check out our blog.

Expert Tips on Picking the Most Suitable Healthcare App Development Company!

Expert Tips on Picking the Most Suitable Healthcare App Development Company!
Healthcare App Development Company
In an era when digital transformation is the buzzword, healthcare mobile apps and solutions are the most viable tools for service providers to elevate their business operations to the next level and deliver an unmatched user experience to patients and doctors. Healthcare solutions enable healthcare providers to offer competent and advanced services to patients, boost profitability, optimize costs, streamline workflow, and obtain interoperability.
However, designing an impeccable medical solution and integrating it successfully with other hospital systems and devices requires proficiency, technical skillsets, and thorough experience. As such, most medical providers, these days, prefer hiring professional app development services to stay competitive and avoid any unwanted glitches. Nevertheless, one must be able to identify the right expertise as there are numerous healthcare development services available around the globe.
This post provides all-inclusive guidance on hiring healthcare app development service assistance. A quick read will help you to identify and pick a development company that best suits your goals and project requirements.

Pick the Best Suited Healthcare App development Company: Factors to Consider

Clearly Define your Healthcare App Development Requirements

Before you move on to hire professional assistance for app development in healthcare, define your business objectives, targeted audience, and your expectation from healthcare developers. Identify your competitors and their profitable strategies; then decide on the strategies you would like to adopt. Also, determine your maximum budget for product development.
The aforesaid practices will put you in a better position to compare the offerings by different software development vendors, make the right selection based on your needs and the project cost, and finally, convey your project requirements clearly to your app development partner.

Understand the Healthcare App Market Requirements

Analyze and research the market requirements of the healthcare sector. If you are a novice in this arena, it is advisable to seek professional help from app development specialists for comprehending the basic needs of healthcare app development, understand how these apps function within a healthcare environment, and gain insights on the programming languages commonly used for crafting such applications. This way, you will be able to look for the right skillset in healthcare app developers and know what you are going to pay for. Also, do not forget to review the existing software development payment models and the average hourly developer rates in different outsourcing destinations. This information will help you in identifying the best-suited option for your healthcare app development project.

Check the Domain-specific Experience and Competency of the Agency

Unlike e-commerce or gaming apps, healthcare apps need to adhere to multiple standards like healthcare interoperability, API integration, etc., and maintain certain security compliance protocols like HIS, HIPAA, etc. Hence, the development team should have extensive experience in handling similar projects and possess domain-specific skillsets for handling complex healthcare app development projects. Healthcare development professionals should also have sound knowledge of API integration processes for building apps pertaining to telemedicine services, clinical assistance, life-sustaining systems, medical information, and so on.
Skilled and experienced developers will understand your business goals as well as the product’s roadmap, suggest the most productive feature-set for your app based on the target audience, know how to effectively integrate the required functionalities, standards, & compliances into your application, and confidently sail through any project-related challenge.
For validating the competence and experience of the healthcare app development agency, you need to check their portfolio, case studies of previous projects, customer reviews & ratings, and awards & recognitions on their website and at renowned business listing portals like GoodFirms, Mobile App Daily, Clutch, etc. Also, verify their market reputation & reach, the kind of healthcare solutions they’ve built in the past, and the technologies they work with. It’ll be even better if you are able to find out the company’s previous track record – whether the firm was able to fulfill client requirements and whether or not the developers have adhered to project delivery deadlines in the past.

Check the Design Principles, Technologies, Tools, and Methodologies proposed for your Project

The design plays a crucial role in defining the user experience of a healthcare application. So, check the previous healthcare products built by the healthcare app development company to understand whether they are capable of creating visually attractive, user-friendly, and intuitive apps.
Also, ensure that your technology partner will be using the latest technologies, tools, effective development methodologies, and best practices for your project. An ideal app development company in healthcare in USA will conduct an initial analysis to gauge the project requirements; create an architectural roadmap based on the app’s structural requirements; possess expertise in programming languages like PHP or Java; and employ advanced technologies & frameworks suitable for healthcare development like Xamarin, React Native, React, Laravel, Swift, Vue, etc.
UI/UX is a driving factor for the success of any healthcare application. So, make sure that the healthcare app development company uses modern tools for building an exceptional and user-friendly UI/UX; and performs exhaustive testing during various phases to guarantee a sound app performance.

Compliance with Security Practices

Sensitive patient data is vulnerable to security breaches and so, most countries have mandated certain regulations on how healthcare data has to be handled by medical service providers. For instance, US medical organizations must comply with HIPAA guidelines. And, if there’s any data breach due to non-compliance with standard regulations, healthcare organizations will damage their reputation, will be fined heavily, and may even face legal charges in case of severe data leaks/breaches ending up losing their license. Hence, a healthcare solution without proper security measures is a threat to patients’ safety and privacy and will cause legal repercussions for providers.
Therefore, the healthcare app development firm should implement the necessary security measures within the app; using software tools such as Auth0 which is standard practice for ensuring healthcare data security and complying with HIPAA regulations.

Validate the Leadership Skills of the Company

If the healthcare app development agency is managed by experienced leadership, the company will be able to provide better clarity and suggestions. Moreover, the firm will have a better understanding of the clinical and administrative workflows of a healthcare organization and be able to devise the best-suited strategies for your facility. Furthermore, the firm will ensure adherence to delivery deadlines and be able to identify and pick talented healthcare developers who are the right fit for your project. An experienced development agency and proficient healthcare app developers can make a huge difference in enhancing the end-product quality, particularly when you intend to build a custom app for your medical services.

Information on the Project Cost, Resources, and Processes

Project cost is an important factor in the entire product development process. So, you must have a tentative budget in your mind before approaching a healthcare app development agency, for project discussion. Communicate your budget to them and clarify which expenses will be incurred by you and what the cost-quality ratio would be like.
Understand the proposed processes and resources allocated for your project to form an idea about the quality of services you’ll get. The standard steps executed by partner IT firms for custom product development include analyzing the requirement, freezing the scope, prototyping the software product, developing the product, QA& testing, deployment, and support maintenance post-deployment. And, the minimum requirement for software professionals include a project manager, UI/UX designer, requirement analyst, app developers, and QA testers.
Make an informed decision only after obtaining full clarity on the aforesaid factors.

Gain Insights on Project Management Process

The app development methodologies adopted by different healthcare software development vendors for building a customized product may vary. As such, ensure that you gather in-depth clear insights on the project management process offered by your vendor. The different processes include agile, scrum, waterfall, and Kanban. Agile means breaking projects into smaller iterative periods, making room for adaptive and simultaneous workflows. Contrarily, the Waterfall method is used for completing projects in a linear way, without any room for going back to the starting phase. Kanban deals with process improvements while Scrum involves speedy development. Your technology partner must explain to you each method in detail so that you are able to pick the most befitting approach that aligns with your product development objectives.
Today, most clients prefer picking a healthcare app development company that will follow an agile development methodology and manage the workflow in scrums. This way, the development teams will gain a better understanding of the uniqueness of your product and will provide flexible methodologies to accommodate the development cycle as per your project requirements. Also, medical end-products need to be scalable enough to meet the ever-changing demands of the healthcare sector. So take clarity on this aspect, at the project discussion stage itself.

Check out the Engagement Models offered and pick the Best Suited One

Check out the engagement models offered by the healthcare app development firm and select the one that suits you best. The prevalent engagement models include the dedicated resource hiring model, fixed price model, and the time & material-based model.
According to the dedicated resource hiring model, clients hire dedicated developers and pay as per the number of hours spent by resources on the project. This model is beneficial if you intend to extend your in-house team, need project flexibility, or there isn’t any clear requirement from your end.
Under the fixed price model, clients put forth their project requirements and the vendor provides a fixed-price quote for such services. Such a model befits projects that have a clearly-defined scope, are of short duration, and projects that involve hiring developers to perform the tasks.
However, if a client requires flexible product development cycles, the client’s requirement is unclear and subject to change, or it’s a long-duration project with dynamic costs, it is advisable to go with the time & material-based model. This model allows clients to hire as per the time taken and the material involved. Here, both parties agree on a mutually decided hourly rate that needs to be paid for the time spent by resources on different project-related tasks.

NDA for maintaining Confidentiality

It is important for you to choose a healthcare app development partner who will sign an NDA (Non-Disclosure Agreement) as this will prevent your product idea to be shared outside the company. So NDA ensures the confidentiality of your project and also enables you to own the code.

Maintenance and Support post-launch

Choose a healthcare app development firm that offers end-to-end product development with maintenance and support post-launch. This is because healthcare software needs to be updated periodically as per the latest software development trends, mobile OS updations, and changing market requirements. Otherwise, an outstanding app today may become outdated next year. Moreover, bugs are likely to crop up post product deployment and the app might encounter runtime snags at any time. For resolving such issues, you need experienced and technically sound software programmers.
Discuss the bug fixing policies to be adopted by your technology partner and the approximate cost of rolling out new updates. Also, make sure that the maintenance policy is transparent from the very beginning of the product lifecycle and they provide formal service and maintenance agreements for the same.

Concluding Lines:

I hope you have gained clear insights on the right processes to follow and the necessary factors to consider while picking the best-suited app development services for your upcoming healthcare app development project. Remember to avoid mistakes like choosing the cheapest vendor available; the product quality is often compromised in such cases. And, you won’t like your healthcare solution to be rated below average or faulty, isn’t it? Also, ensure that you optimize your product for the app store and make adequate preparations well in advance for the app launch.