Healthcare software development is one of the main tendencies of 2020, and there is nothing to be surprised about. Given the experts’ forecasts, the COVID-19 pandemic is here to stay, and, thus, the telehealth and MedTech industries will continue growing at a tremendous pace. Sure enough, the telehealth domain was well off without the pandemic. Whereas now, it is going to develop even faster as the latest market analysis shows that the global Medtech market will reach the point of 17.2 billion by the end of 2025, which is an average compound annual growth rate (CAGR) of 24.1%. The stats are impressive, and so is the future of the telehealth industry.
Too many developers with brilliant projects in the pipeline stumble upon the same barrier – the legal codes of their target markets regulating every aspect of the product, from UI/UX to app’s architecture. Medical software developers fail to understand why their ideas may be hanging in the balance due to a single law provision. The answer is clear to understand: this is the world of sensitive data that we live in, and any healthcare software should make their products become HIPAA compliant and NHS certified. That is why, in this article, we will discuss the HIPAA and NHS regulations – the two landmark regulatory systems for healthcare software developers.
Why We Need Them
There are a lot of reasons why a healthcare software developer needs to stick to, let’s say, HIPAA guidelines. The laws and regulations mentioned above represent the legal basis for the successful functioning of your app. Given the increased sensitivity of people’s data, security in healthcare became a central concern in the United States and the United Kingdom – the two biggest markets of the telehealth industry.
Every company, eager to provide healthcare security solutions for those markets, has to stick to the patient data security provisions laid out in HIPAA and NHS regulations. Here comes a stepwise guide to how to be a HIPAA and NHS compliant healthcare software developer.
HIPAA Compliance and Certification
The U.S Congress adopted the Health Insurance Portability and Accountability Act in 1996 – the time when the Internet had nothing in common with healthcare; talking about HIPAA and Electronic Medical Records as mutually related concepts was complete nonsense.
However, the updated HIPAA features a myriad of guidelines to follow if you want your software to be compliant and thus eligible for use on the United States territory. Following thorough research, we have boiled the list down to five main points adhering to which will give you the HIPAA Compliance Certificate.
The Obama administration 2009 HITECH Act that fixed the HIPAA loopholes in the development of health information technology regulations. It has mandated external audits of every single healthcare software platform aimed to ensure that the software in question is compliant with the HIPAA patients’ information safety provisions.
As a result, the first thing that a product has to have to meet the HIPAA compliance requirements is a logging infrastructure that does not resist regulatory compliance. For example, you can use AWS’ CloudTrail to log the API calls, and when the audit time comes, these tools will bring you the evidence of compliance.
Under the Technical Safeguard Standard of HIPAA’s Administrative Simplification Security Rule, there are four essential features to be embedded into the product’s access control:
- Unique user identification patterns;
- Personnel/role-based authorization;
- Automatic log-off;
- Emergency access;
Centralized Identity Management
Authorizing users and defining their identity is another core requirement for developing HIPAA compliant software. Software developers have to devise the ways their products are going to track the logins, log-offs, users’ activity, sessions, and changes in the profiles. Nonetheless, the security measures are not to hinder the users’ experience and needs.
Sometimes, inefficient EMR software development can lead to lamentable consequences. For instance, a doctor must be able to access the files needed within a matter of seconds, as there might be a crucial decision pending due to the information logged in the EMR system.
PHI and Sensitive Data Encryption and Decryption
As a matter of fact, HIPAA does not directly require the encryption of PHI. Nonetheless, reassuring your clients that their patients’ data is being protected in a due manner is essential in modern software development. Regardless of whether it is the data at rest or in transit, encrypt it using the purpose-design approach as it will prevent any probable case of patients’ data loss, and thus eventual financial risks and liabilities. All the data within the system must be encrypted and decrypted only by authorized personnel with corresponding digital keys.
Data Transmission Security
While HIPAA is not requesting any particular data transmission security measures, they are clearly laid out in the HITECH Act. Ensuring data transmission security is a core practice in modern healthcare software development, as it prevents unauthorized access to electronically transmitted data, which, in fact, is the primary HIPAA requirement. Thus, consider building your products with TLS and SSL certification and do not forget about object keys where needed.
Of course, the full list of HIPAA requirements is way more extensive, and the applicable provisions can be defined based on the specific properties of your product. But, following these five major rules shall definitely help your product reach its target markets.
Dental clinics worldwide are now joining the process of EMR and EHR reintegration to help healthcare systems efficiently manage patients and their doctoral referrals. As a result, following the dental HIPAA compliance requirements is a rule that they must follow. There are three major categories to divide HIPAA into when it comes to talking about dental clinics: administrative, physical, and, of course, technical.
The latter does not differ a lot from the overall EMR HIPAA compliance regulations. Protecting the patients’ data and ensuring its encryption, decryption, and personnel authorization is a must. If you want to have a somewhat realistic look at applying the HIPAA provisions to a real project for a network of dental clinics from the UK, check our Dental Referrals case study.
NHS Compliance and Certification
Developing healthcare software for British markets is quite a complicated process, as the UK National Health Service is quite picky when it comes to Whereas in the United States, your product has to be HIPAA compliant and get an FDA certification, in England, for example, there are a lot more legal boxes to tick before launching your product.
You must embark upon four steps when developing software for Continuous Healthcare (CHC) organizations in the United Kingdom. While scrutinizing the complete NHS CHC checklist might be a long and tedious process, reaching the healthcare regulations and compliance standards is undoubtedly worth it.
- The app is publicly available on AppStore or GooglePlay;
- The product users can contact the developer directly;
- The product is not NHS branded;
- The product’s interoperability testing has been conducted, given the product’s need to connect to other NHS service;
- If the product falls under the classification of a medical device, it must hold a corresponding certificate;
- If the product requires a healthcare professional operator, the developer must provide his or her name and healthcare professional registration status;
- The developer must be registered with the Care Quality Commission on a request;
Register the Details
- The developer’s registered address;
- Contact information of the person conducting the assessment;
- Information regarding the developer’s Care Quality Commission registration;
- The healthcare direction the software addresses;
- The software target audience;
- The software price;
- Providing the Outcomes Evidence
- Clinical Safety
- Data Protection
- Usability and Accessibility
- Technical Stability
Publishing the App
- Any significant update to the software is subject to disclosure to NHS;
- Any changes to the DAQ will be relayed to the developer with a corresponding request to change the product according to the new requirements.
The HMS Software Compliance Principles
- The system must be easy to understand for any medical employee;
- The UI/UX aspect must be understandable and easily accessible;
- The personnel access principle must be the core one;
- All the personal data must be encrypted;
- The software must demonstrate the potential for improving the clinical practices in the hospital;
Let’s Sum It Up
One can clearly see that following HIPAA and NHS regulations is a justifiable requirement. Ticking off the HIPAA security checklist, as well as following the NHS security assessment process, must be every healthcare software developer’s major priority. We will definitely dig deeper into this topic, including HIPAA cloud security, FDA security requirements, extended list of NHS healthcare data compliance requirements, and GDPR guidelines, as this is a vital topic to discuss.