Cybersecurity is a major issue in medical software development – and becoming more critical every day. For the fifth year in a row, 2020 saw an increase in reported hacking attacks on healthcare solutions – 42% more than in 2019. The U.S. Department of Health and Human Services reports over a million people each month last year affected by data breaches in healthcare systems. We’ve seen high-profile ransom attacks on hospitals around the world, and more than 80% of medical practices in the U.S. have been the victims of cyberattacks. In Europe and the Middle East, security incidents have seen an increase of about 125%.

Part of the reason for this increase is simply that there are more and more connected healthcare devices and systems in use today. That means there are more targets to attack and more patient data to be stolen. In addition, the increasing importance of connected healthcare services means that patients and care providers are becoming more reliant on the availability of these services. As a result, many attackers have targeted hospitals and other healthcare organizations by encrypting their data or disrupting their systems via DDoS (Denial of Service) attacks. Because this can pose critical dangers to patient health and safety, these organizations have had no choice but to pay ransoms to the attackers to restore their services and data.

As a result, any company developing connected medical software solutions today needs to make security an integral part of every aspect of their development process. Security can’t be an afterthought: if you aren’t incorporating security into your SDLC right from the beginning, you’re likely to wind up with a vulnerable solution.

What kinds of threats does medical software development need to keep in mind? Typical attacks are carried out either by exploiting bugs, vulnerabilities and insecure code, or via social engineering, where hackers gain access to your systems through phishing attacks or other means of getting users to provide their login and access credentials.

Aspects of your service that it’s critical to secure include:

  1. Encryption of data stored on your system
  2. Secure transfer of data between different parts of your system (e.g., from a user’s remote care device to the cloud) or between different systems (e.g., from your servers to a healthcare organization’s servers)
  3. Password policy & MFA (Multi-Factor Authentication)
  4. Cloud infrastructure security
  5. Security audits & monitoring
  6. Availability & survivability to ensure users can continue to access your service in case of attack

As you can see, effective security touches every point in the software lifecycle: planning, development, testing, and deployment in the real world. It requires solid security expertise that is always up-to-date with the constantly evolving cybersecurity landscape.

Not only is strong security critical for protecting your customers’ privacy and safety, but it’s also an absolute requirement for regulatory approval. The FDA and CE regard security as one of the most important parts of their approval processes; these days, insecure devices will not make it to the market. In addition, security breaches after devices are deployed by customers are a minefield for legal liability. More and more lawsuits are being launched against healthcare organizations and software and device makers for insufficient protection of patient safety and privacy. To protect your company, you must be able to demonstrate that you have fully implemented the highest level of security possible throughout your development process.

At Medika, building secured, survivable systems for healthcare solutions is in our DNA. With over a decade’s worth of experience, we can help your company create reliable systems that customers can trust. For a free consultation with our experts, contact us!