The global market for medical device security totaled $4.7 billion in 2016. The market should total $5.2 billion in 2017 and $7.5 billion by 2022, increasing at a compound annual growth rate (CAGR) 7.4% from 2017 to 2022.
This report covers the global market for medical device security technologies and provides regional analyses of the markets in North America, Latin America, Europe, Middle East and Africa (EMEA) and Asia-Pacific. Component segments include chip sets, platforms, software, and services. The market is also segmented by end users such as providers, payers and manufacturers. Further, application areas such as consumer, wearable, embedded, and in-hospital devices are sized.
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– An overview of the global market for medical device security technologies.
– Analyses of global market trends, with data from 2016, estimates for 2017, and projections of compound annual growth rates (CAGRs) through 2022.
– Analyses of the market by technology, end user, application, and region.
– Discussion of the market opportunities for manufacturers, software firms, and services firms.
– Insight into the patent review and new developments in the market.
– Profiles of major companies in the industry.
For patients, healthcare providers and device manufacturers, cybersecurity in healthcare is “the wild wild west”, according to Josh Singletary, CIO for the National Health Information Sharing and Analysis Center (NH-ISAC). Singletary is referring to the number and types of threats, which range from ransomware to credential harvesting. The motivation in most cases is financial as healthcare associations report that protected heath information (PHI) records are worth $50 each on the black
market, which is six times the value of a social security number. Credential harvesting can be used to access PHI records or for other aspects of identity theft in addition to credit card or other financial data. Most recently, ransomware such as WannaCry simply locked down internal systems until the medical provider paid a ransom via Bitcoin.
Protecting against these varied and increasingly sophisticated attacks is difficult as the medical information system footprint is quite large with multiple entry points. Providers must consider incursions across the entire stack of systems, ranging from enterprise IT infrastructure to networks and end points, especially medical devices.
In this environment, medical devices can be major entry points into vulnerable healthcare systems. “Devices have risks, you need to know them and work them,” Kevin Fu, CEO of Virta Laboratories and an associate professor and leading research participant for the Archimedes Center for Medical Device Security at the University of Michigan, has stated.
The state of vulnerability of medical devices increased in phases. Initially, there were few incursions so over time, legacy devices were deployed with minimal security. Within the last few years, however, the capability to access medical devices via remote wireless signals has ratcheted up risk. A few recent cases include:
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– Johnson & Johnson famously became the first device manufacturer to issue a security warning. The warning was regarding its Animus OneTouch Ping Insulin Pump, which could be accessed through unencrypted wireless remote communications to trigger a potential overdose.
– In another famous case, a consultant was able to remotely activate a pacemaker, giving him the ability to administer a potentially fatal shock.
– According to the Identity Theft Resource Center, more than 300 security breaches were reported by healthcare facilities in 2017, exposing 1.3 million patient records.
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Responding to these threats, the U.S. FDA has set pre-market guidelines for cybersecurity risk management manufacturers. While these guidelines address new devices in the design and pre-approval phases, the FDA has also issued guidelines for post-market security, which affect the minimally protected installed base of legacy devices. These requirements require manufacturers to address security threats throughout the device lifecycle. The guidelines are stimulating new investment in
hardware and software security by device manufacturers. Alongside this new investment in new spending by healthcare providers, who are deploying their own hardware and software security systems and hiring third-party monitoring, threat assessment and risk management services.