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Industry compliance should be at the forefront of any healthcare startup’s strategy. In healthcare, key regulations serve as the mandatory framework for developing all desktop and mobile solutions. Failure to comply with these regulations means that your software or/or applications will be rejected from the market.
In the saturated health tech industry, having healthcare solutions that are in compliance with new rules and legislative norms is a significant determinant of success. When it comes to the risk of exposing sensitive patient information, the stakes are simply too high. As such, the slightest mistake can be extremely costly for all parties concerned.
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HIPAA stands for the Health Insurance Portability and Accountability Act. This US healthcare industry regulation was first developed in 1996. In essence, it’s a federal law that mandates the development of national standards to prevent sensitive patient health information from being revealed without the agreement or knowledge of a patient.
Healthcare providers, clearinghouses, business associates, and healthcare plans are all subject to compliance with the HIPAA law. The rule is a backbone of healthcare regulatory branch, and there are many HIPAA benefits for healthcare providers.
It’s no secret that regulatory compliance is a big deal in the healthcare business — especially when it comes to technological advancement. Given the level of sensitivity regarding medical data, any breach or discrepancy can lead to costly and inconvenient consequences for patients, as well as healthcare software suppliers and medical institutions.
When it comes to technology, it’s clear that industrial digitization is a leading cause of compliance concerns. Many data-enabled systems violate various industry rules, resulting in data privacy concerns.
The problem of healthcare regulations is a challenging one, as there are several regulations and guidelines that continuously change over time. Patient privacy is well protected by general standards such as the EU’s GDPR and medical-specific laws, including HIPAA in the United States.
In addition, the Food and Drug Administration (FDA) adopted a Medical Device Reporting (MDR) law in 2015 that requires medical device businesses to disclose any adverse concerns with their goods and services to the FDA. As a result, when digitalization and technological intervention become intertwined with a healthcare business, maintaining compliance poses several obstacles.
PHI stands for Protected Health Information. It refers to a class of data identifiers that are under specific protection of the HIPAA law. In total, there are 18 information units that are subject to HIPAA.
PHI data includes patient names, phone numbers, location, IP addresses, photos and ID documents, Social Security numbers, medical records, account numbers, and much more.
HIPAA compliance is necessary for all healthcare applications. Hospitals and healthcare providers that fail to comply with HIPAA regulations are subject to significant fines. Although an individual data breach can cost upwards of $50,000, it can result in losses of millions in total damage.
HIPAA has stringent regulations for the processing, transferring, and storage of personal data. Any modern IT architecture is built on a modular, microservices-based foundation. In short, it’s the engineering team’s responsibility to ensure that system safety standards are met when developing HIPAA-compliant apps.
It’s important to be aware that HIPAA compliance often requires more than technical implementation, including:
One of the most important aspects of the HIPAA criteria is that patient information and records can only be accessed by authorized medical personnel. Internal spying is, unfortunately, a common occurrence in the healthcare industry.
In fact, according to a 2018 Verizon PHI Data Breach Report, many medical professionals have access to information they shouldn’t, whether purposefully or unintentionally, resulting in 56 percent of security interventions. In addition to properly training staff, artificial intelligence and deep learning can also identify and prevent compliance infractions through rigorous access control.
To develop a HIPAA-compliant app, developers must ensure that all processes and transactions follow the specified flow (laid out in the HIPAA act). Any departure from the set procedures will be detected instantly. Payment and audits are successfully handled by an algorithm that ensures pharmaceutical inventory figures add up.
The amount of diverse data sources and formats that must be handled and evaluated all add to the overall complexity. Traditionally, pharmacovigilance was carried out by massive teams of doctors who gathered information on the effects of medication and patient response. Any data processing inconsistency in these reports posed a danger to regulatory compliance.
Thanks to AI-based solutions, data collecting, analyzing, and processing is streamlined and automated, which significantly reduces the chances of human error. As a result, there is less room for regulators to question the validity of an application.
This also simplifies the process of receiving and processing structured and unstructured data as AI can extract the required regulatory data from given sources of information. Furthermore, AI can detect patterns and suggest better methods for decision-making regarding treatment dosage, prescriptions, patient data, etc.
As the healthcare business progressively migrates to digital platforms, data security has become a major point of interest. Privacy restrictions, according to Gartner, are top-risks for most firms, including those in healthcare.
Given that 41 million medical records were compromised in 2019, this is a major problem. The accumulation of sensitive patient data, medical institution records, and smart data from healthcare wearables act as a target for damaging and costly cyberattacks and data breaches.
There have been countless instances where a single data breach or a pattern of non-compliance with the HIPAA requirements has resulted in significant financial losses.
Because there are various types of data sources and levels, the conversation concerning artificial intelligence for healthcare data security is lengthy and varied. When it comes to compliance, however, the primary US medical regulatory set, HIPAA, regulates some forms of patient data. As a result, when developing a HIPAA-compliant mobile app, organizations and developers must adhere to these standards.
The overall cost is determined by a variety of elements, including the complexity of a product, the duration of development, technology stack, team size, development rate, and more.
Technical documentation, design, programming, development, prototyping, maintenance, project management, and quality assurance are all important components of fitness app development.
The more complex a healthcare application is, the more stages will be involved. The average time it takes to build an app is four months. However, depending on an application’s complexity and scale, it may take longer.
A full-featured HIPAA-compliant app costs, on average, roughly $50,000. This cost covers the creation of the entire system which must fulfill both physical and technical security requirements. Developers will also need to spend time inspecting the system and obtaining the necessary certifications, among other things.
Rather than designing a HIPAA-compliant mobile app from scratch, developers may employ HIPAA-compliant infrastructure and solutions. However, when working with third-party providers, it’s up to you to ensure they are dependable when it comes to storing and processing PHI.
You won’t be able to meet all of the necessary HIPAA regulations without assistance from a professional developer if you don’t have the relevant experience. As a result, it’s preferable to partner with an experienced software provider that can assist you with crucial consulting and system auditing.
It’s better to opt for an experienced team to handle the entire HIPAA-compliant app development process. We recommend pairing with an expert company that has a proven track record with similar solutions, whether you are a startup or a large healthcare business.
To encrypt a patient’s sensitive information, strict security procedures must be followed. First, make sure there aren’t any security flaws. Use different levels of encryption and obfuscation to prevent data from being lost or stolen.
Encryption is essential when it comes to developing a secure HIPAA-compliant application. Using blockchain technology in the development process can help build data integrity and security.
It’s critical to test mobile apps on a regular basis, especially after an upgrade. You should dynamically and statistically test a solution to make sure it’s in compliance with HIPAA. Furthermore, take advantage of professional consultation to double-check that your documentation remains up-to-date.
Tools, libraries, and frameworks aid in the development of applications and guarantees that security is maintained at all times. For example, once you’ve created a HIPAA-compliant mHealth app, you need to be sure to update it on a regular basis to avoid a security breach.
Glorium has the expertise and capacity to enhance your healthcare solutions. Whether you require IT consultation, robust application testing, or assistance building a HIPAA-compliant mobile app — we’re here to help.
With extensive experience developing medical software and a profound understanding of HIPAA rules and other critical regulations, we understand the key hurdles that healthcare software providers must overcome.
Eliminating risk for both your company and customers is a priority that cannot be compromised. Learn more about our healthcare software and application development solutions today.
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