The marriage of healthcare and technology promised a horizon of hope. In this world, ailments are diagnosed swiftly, medical records are but a click away, and healthcare services break the bounds of distance. Yet, as with any profound transformation, came adversaries that eyed the treasure trove of sensitive data now coursing through digital veins.

Healthcare is an industry that often deals with different types of patient-sensitive data. Cyber attackers saw the value in the data healthcare providers stored – a treasure trove of personal and medical information that could be exploited for malicious or monetary purposes. This realization brought forth a harsh reality; the digital healthcare landscape was fertile ground for cyber threats, making data security a paramount concern. When you’re about to develop your healthcare custom digital product, you’re probably aware of the fact that healthcare data security is crucial in this industry.

The narrative of data security in healthcare software development is one of resilience, continuous learning, and adaptation to the shifting contours of cyber threats. It’s a commitment to a safer digital healthcare ecosystem where the privacy and security of patient data are held in the highest regard. This blog post dives into the significance of data security in healthcare software development, exploring the legislative frameworks guiding data protection, the evolving nature of cyber threats, and the comprehensive strategies required to mitigate data security risks.

What is data security in the healthcare industry about?

When the internet was born, no one thought about data security. As the world began to digitize more and more, cyber attacks, data theft, and their use for evil purposes started to occur more and more frequently. Nowadays, increasingly aware users greatly emphasize how their data is protected. If you’re a medical software provider and you really care about your clients, you should take data protection seriously. The seriousness of the issue is shown by various research and statistics. The Healthcare Breach Statistics conducted by HIPAA’s journal has discovered that between 2009 and 2019, the number of data breaches increased from 18 to 510.

According to The State of Ransomware in Healthcare 2023, conducted through 233 IT/cybersecurity professionals across 14 countries, which aim was to explore the topic of security threats deeply, the key findings were as follows:

  • Trend in Ransomware Attacks:
    • A dip is witnessed in the rate of ransomware attacks, sliding from 66% to 60% year over year, albeit a stark rise from the 34% reported back in 2021.
  • Escalation in Data Encryption:
    • Post-attack data encryption surged to 73% in 2023, ascending from 61% in 2022, marking a continuous upward trajectory over the last three years.
  • The Emergence of Double Dip Attacks:
    • In 37% of the incidents, attackers both encrypted and exfiltrated data, indicating a growing preference for this “double dip” technique.
  • Primary Attack Vectors:
    • The culprits? Compromised credentials lead at 32%, followed by exploited vulnerabilities at 29%, with email-based onslaughts initiating 36% of the attacks.
  • Navigating the Road to Data Recovery:
    • A beacon of hope as healthcare organizations achieved a 100% data recovery rate.
    • A shift in tactics is seen with a drop in ransom payments from 61% to 42% year over year, while the use of backups for data restoration slightly rose from 72% to 73%.
  • The Financial Toll:
    • The pathway to recovery got pricier, with costs escalating from $1.85M to $2.20M year over year, almost doubling the $1.27M reported in 2021.

This report underlines the imperative of evolving cybersecurity measures to stay a step ahead of the nefarious advancements in ransomware tactics, ensuring a fortified healthcare sector resilient to the cyber onslaught.

why data security is critical in healthcare

Types of security standards for healthcare software development

A few different types of laws in the HealthTech industry protect patient data, depending on the region in which they apply.

1. Europe: General Data Protection Regulation (GDPR)

The GDPR was created and implemented in 2018 and was intended to manage the flow of data and protect the personal data of Europeans. Thus, every healthcare digital product is obliged to be GDPR compliant. Nowadays, patients are more and more aware of the importance of data security, and that’s why they put a strong emphasis on data security standards. Contrary to HIPAA, GDPR wasn’t customized precisely for mobile applications, so its compliance regulations are much more universal.

At first, you, as a healthcare provider, are obliged to inform the users of your healthcare mobile about the process of collecting and administrating their data and your reasons for that procedure. Secondly, you have to obtain consent for handling their data and anonymize gathered patient records, allowing them to withdraw this consent at any time at their request. If any data breach occurs, the user must also be informed about it.

2. United States: Health Insurance Portability and Accountability Act (HIPAA)

When it comes to data security in healthcare in the United States region, a law was introduced called HIPAA. When should the HIPAA protection law be applied? Every time a HealthTech application is released to the US market. Its goal is to ensure the protection of any health information and medical records of patients. How can you make your app HIPAA-compliant?

  • Personal medical data encryption (at the moment when it’s collected on the device and at the moment when it’s transferred to the server),
  • 2-factor authentication,
  • Systematic tests, and updates,
  • Implementation of a feature that automatically logs off the users if they don’t use the app for some time.

The penalty for breaking this law can be up to $ 1.5 million per violation.

3. Canada: Personal Information Protection and Electronic Documents Act (PIPEDA)

When you live in Canada, you have to deal with PIPEDA regarding data security standards. According to this law, personal data includes names, ID numbers, health records, credit card numbers, etc. PIPEDA works similarly to GDPR. As a healthcare software provider, you are committed to informing the users about collecting and processing their private data, your reasons for doing that, and obtaining user consent for this process. Also, the data should be deleted if they’re not required anymore or at the user’s request.

why data security is critical in healthcare

What are the primary data security challenges in the digital health industry?

The healthcare industry also has to face different challenges and issues when it comes to data security, for example:

  • Outdated infrastructure due to the high costs of its maintenance,
  • A growing number of cyber attacks, especially with the increase in Electronic Health Records (digital version of a patient file for a single medical facility),
  • Medical personnel is often unaware and untrained in the issues of cyber threats,
  • The connection of the healthcare industry to many different service providers and vendors is what makes it challenging to discover where the healthcare data breach occurs,
  • And more.

How do you deal with data security challenges in custom healthcare software development?

The healthcare sector is fertile for innovation, with custom software development at the core of many transformative solutions. However, as the digital health landscape expands, so does the surface for potential cyber threats. Tackling data security challenges requires a robust approach rooted in stringent standards and certifications that validate the efficacy and safety of healthcare software solutions.

ISO 13485: A keystone for healthcare software development

ISO 13485 is a globally recognized standard that outlines the requirements for a quality management system (QMS). An organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. While traditionally associated with medical device manufacturing, its principles are exceedingly relevant and beneficial for healthcare software development companies to be ISO 13485-certified company.

Adhering to ISO 13485 standards signifies a commitment to meeting the stringent regulatory and legal requirements specific to the healthcare industry. It facilitates more straightforward navigation through the complex regulatory landscape, ensuring that the developed custom software complies with global and local health data protection laws.

Addressing the challenges for software solutions

Handling data security challenges in healthcare software development services is a multidimensional effort. Apart from aligning with ISO 13485, it’s pivotal to foster a culture of security within the organization, engage in regular training and awareness programs, and employ a holistic cybersecurity strategy encompassing the latest encryption technologies, robust authentication mechanisms, systematic testing, and timely updates.

Moreover, collaborating with cybersecurity experts and staying abreast of evolving threat vectors and regulatory requirements is essential. A concerted effort towards building and maintaining secure healthcare software protects sensitive health data. It significantly contributes to the overall enhancement of healthcare services, paving the way for a safer and more efficient digital health ecosystem.


Do you want to find out more about data security in HealthTech?

Talk to us!

Cybersecurity in custom healthcare software development matters

Healthcare is one of the industries most vulnerable to cyber attacks due to the specificity of the collected data. That’s why it’s a matter of utmost importance to take care of healthcare data protection when creating a HealthTech digital product with software developers. However, if you’re curious about other challenges you will face while developing healthcare digital products, you can find out more in our Master the HealthTech guide.