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July 27, 2020

Digitalization: Macroeconomic and Regulatory Trends

Digitalization of medical devices has become more prevalent in the past few years, and GlobalData predicts that this trend will continue and accelerate in the next 10 years. However, as more medical devices become connected and health records are shared among various stakeholders, the threat of cyberattacks becomes more worrisome. Cyberattacks can seriously affect a company’s operations, finances, and reputation.

Listed below are the key macroeconomic and regulatory trends impacting digitalization in medical devices industry, as identified by GlobalData.

Mergers and acquisitions

Mergers and acquisitions are continuously occurring in this space. As smaller companies push the technological boundaries for innovative digitalized medical devices, larger companies see opportunities to fill gaps in their portfolios through M&As.

Strategic partnerships

Partnering with established technology providers is an excellent way for medical device companies to integrate technology and digitalization into their organisations. Examples of this strategy include Medtronic‘s partnership with IBM cloud services for mobile, real-time glucose insights, as well as Philip’s partnership with Salesforce and Amazon for HealthSuite.

FDA regulations

The FDA, in collaboration with US Department of Homeland Security (DHS), is tasked with ensuring the security of medical devices in US. Medical device manufactures need to comply with quality system regulations (QSRs), which include the mitigation of cybersecurity risks. The FDA has recently released a new cybersecurity playbook to outline guidelines for medical device software.

HIPAA

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a US legislation that protects medical data privacy and security. Medical device manufactures need to keep this legislation in mind when developing connected medical devices.

General Data Protection Regulation (GDPR)

The GDPR is a regulation in EU law about data protection and the privacy of EU and European Economic Area residents. Medical device manufactures need to keep this regulation in mind when developing connected medical devices.

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CE mark

Software or apps that fall under the medical devices category must have CE mark prior to it being commercially available in the European market.

This is an edited extract from the Digitalization in the Medical Devices Sector – Thematic Research report produced by GlobalData Thematic Research.

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