
American Law is Just as Relevant in Europe as the USA
European health technology firms are already complying with GDPR and other EU regulatory requirements. Ho...
Head of Business Analysis
Development for digital health solutions can be extremely challenging. It has the potential to be fraught with compliance issues.
Health technologies like apps and web services can require databases of patient or user information. This might include information like names, addresses, prescriptions and more.
All of this information is sensitive. Breaches of privacy can carry hefty fines, and affect the trust of a technology solution.
Depending on the identification of this data, HIPAA regulations are extremely important. Consider whether your teams are up to speed on the necessary rules, regulations and safeguards for secure digital health development.
These regulations were created to increase the safety of personal information. HIPAA represents the security of personal health information, in particular.
The HIPAA regulations require increased security awareness around personal health information. This information is protected, from all unauthorized access. This data is individually identifiable, and could lead to the identification of a patient or user.
The privacy rule is applicable to all personal health information, whether physical, digital or spoken.
Personal health information might refer to the demographic data of a patient. However, personal information is the major safeguarding issue for HIPAA. Personal details might include, names, addresses, or any information related to health conditions throughout a person's lifetime.
HIPAA and the Privacy Act’s main aim is to prevent unlawful disclosure of information, without prior consent.
Typically, people only think of healthcare providers to be bound by HIPAA. While that may be, the regulations’ reach is more expansive.
HIPAA compliance is critical to any healthcare organization that holds or transfers health information. This does include physicians, hospitals, insurance and more. However, it also includes business associates.
Business associates can be any organization that handles personal health information, on behalf of the healthcare industry. Chances are, that includes your business and your digital health development.
Your health technology solution needs to be HIPAA compliant. This is necessary regardless of whether your innovation is created in-house, or for another healthcare organization. Your development teams are at the heart of your build.
Firstly, it is key that quality assurance and testing teams are familiar with HIPAA requirements. Ultimately, these employees are the final barrier for compliance. Your QA’s need to ensure that the entirety of the digital health solution is HIPAA compliant, before release. It’s also important to bear in mind that, for some teams, HIPAA training might be mandatory, too.
However, prevention is better than treatment. This saying isn’t just applicable to patient healthcare. Your development should be built with compliance in mind, rather than catching issues at the last minute.
Train all of your development teams, from planning, building and testing. Mistakes can be extremely costly. Your solution should be built by staff that are aware of HIPAA, at every stage. This ensures that errors are as limited as possible, and the build is cohesive on release.
Training for compliance can present new challenges. It is extremely important that it is as accurate as possible. Teams need to be trained consistently, and progress monitored. Consider a company-wide training programme, to ensure all staff are up to speed. Ultimately, this benefits your entire digital health build.
HIPAA and compliance regulations change and evolve over time. As new violation cases arise, and new technologies, data protection needs to evolve with the landscape.
The last major update to HIPAA rules was in 2013. Since then, new legal cases have arisen, presenting new challenges for the compliance law to tackle. As a result, it is expected that updates will come in 2022. All health care organizations will be responsible for keeping those who handle sensitive data updated on the changes.
Therefore, HIPAA privacy training should develop, too. Your teams need to be up to date with the latest developments in all areas of compliance. This should be the case throughout major regulatory changes, and minor updates.
Conduct regular training sessions with your teams. Courses and training programmes should run for each update, and for each new joiner. You might wish to put new developers through training as an onboarding process.
This method is preventative. Your development will always be up to date with the newest requirements, throughout each step of the build process. Avoid being caught out by HIPAA changes at the wrong time.
HIPAA and Privacy Rule training can be extensive. Compliance is a challenging subject. However, it is critical that your development teams have a comprehensive understanding of requirements. Therefore, chances are, it will require more than one training session to ensure all information is covered.
Good training is never complete, though. People naturally forget information over time. Unfortunately, this isn’t a risk worth taking for compliance in health technology development.
Plan regular training sessions for each team. This ensures maximum retention of the necessary information. Development teams are learning new skills every day, so their learning needs to be revisited.
Consider the most engaging ways to educate your developers. As mentioned, compliance training isn’t always the easiest thing. It is also difficult to learn. Encourage group learning, and interactive projects. Ultimately, the right training could save the development.
Risk assessments and preventative measures are key components of successful compliance. They allow you to put safeguards in place. This avoids any major compliance errors, before they occur.
Planning ahead of time is key. In the end, development teams are best placed to analyse the risks posed by their build.
Your training needs to cover the basic information regarding HIPAA and compliance. However, training should also push for further development. It is important that developers learn to associate their tasks with compliance, and begin to identify compliance problems.
HIPAA requires regular risk assessments. This is an opportunity for development teams to understand the significance of keeping to safeguards, and identifying risks.
Train them to conduct their own risk assessments, and encourage them to highlight their concerns. Potentially, their observations could save the organization from massive financial losses.
At Vertrical, we have teams of developers with expert compliance knowledge. We are guided by HIPAA and all necessary compliance regulations for digital health development. Get in touch today to discuss how our developers can ensure maximum security on your next project.
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