Digital Health Security & Compliance
Modern medical devices have allowed the medical sector to deliver healthcare services more efficiently and effectively than ever before. However, their digital connection to networks and other systems expose them to cybersecurity risks that have become increasingly common due to the highly sensitive data they hold.
Risks include the denial of intended service or therapy, alteration of device functionality that could cause patient harm, access to other systems and devices in the network, and loss of private or sensitive data. Many of the current healthcare and medical cybersecurity solutions don’t cater for a holistic view of digital health security and compliance. That’s why working with Comsec can help you:
- Rest assured that you’re secure with the most up-to-date expertise in the industry. Comsec works closely with governing offices and innovation programmes such as H2020 in order to become best-in-class experts for digital health security and compliance worldwide.
- Additionally, Comsec is involved in national processes and decisions, lecturing at leading conferences, and writing new methodologies in partnership with regulators.
- Maintain and protect your organization’s reputation among patients, business partners, investors, and governing bodies in a highly sensitive industry
- Approach digital health security with a holistic, proven methodology that leans on best-practice ISO 27000 series compliance standards, including ISO 27001 and 27799.
- Reduce the risk of costly data breaches, legal action, and damage control from successful cyber attacks
How Comsec’s Digital Health Security and Compliance experts help your business
Comsec’s experts have vast experience in managing, guiding, and securing organizations in the medical field including hospitals, clinics, tech companies, and more to ensure all relevant cyber security standards are met with regards to medical devices.
A medical device is defined by the FDA as an instrument, device, appliance, software or material that is intended for use in the diagnosis, monitoring, or treatment of diseases and other medical conditions.
Comsec aims for the highest, most holistic compliance standards such as ISO 27001 which follows an established process of asset mapping, risk assessment, and gap analysis in order to mitigate any identified risks at your organization. This is especially important in organizations with multiple departments, devices and processes where a lack of coordination between them may create weak links in the security chain.
Comsec’s dedicated digital health security and compliance experts will begin by gaining a full understanding of your business. This may involve in-person interviews, documentation reviews, and hands-on evaluation of your technology stack. We will then compare your organization’s current security standards against ISO 27001 information security standard, as well as any other relevant regulations to your business. During this phase, we will build an asset mapping registry to include inventory. We will also perform a risk assessment to determine the potential loss of confidentiality, integrity, and availability (CIA) of information. Finally, we report on the gap analysis including a recommendation to mitigate them based on priority. We can also help to certify you for any compliance needed.
Following the overall goal of ISO 27K series compliance, a range of more granular regulations are met depending on your specific circumstances, including but not limited to:
- ISO 13485 (quality management systems for medical devices)
- ISO 27799 (healthcare information security standards)
- IPPE (regulations for databases containing personal data)
- GDPR (specific privacy regulations for EU businesses)
- CPPA (US-based framework for managing, maintaining, and transmitting confidential medical information)
- CE (licence for importing and marketing medical devices in EU countries)
- FDA (ensures medical device benefits outweigh the risks to patients)
- ARTG (an Australian-based register of therapeutic goods to ensure local regulations are followed for medical devices)
- IEC 62304:2006 (defines the requirements for medical device software lifecycle
Over 30 years of cybersecurity experience
- Comsec is trusted by over 1,000 clients including Fortune 500 companies
- Our international offices ensure quick response times, any day of the week
- Work with enterprise-level, certified professionals with top-tier credentials
- Find solutions quickly based on Comsec’s gold-standard Isreali cybersecurity expertise
- Comsec is certified as a QSA for PCI-DSS and our consultants are ISO 2700 Lead Auditor and Lead Implementer certified
