Maslow’s hierarchy of needs, depicted in the form of a pyramid establishes the changing human needs with general progression in life that affects Individual lifestyle. External factors contributing to the level of dynamism in re-defining “lifestyle” of generations would be — technological advancement and general prosperity in society.

Wireless is one such technology that touches user lifestyle right from mobile telephony to wireless power in device operation; the very fundamentals of applications have been revolutionized with a touch of wireless technology.

Medical Electronics, in particular, have benefitted from the advancement in Wireless Communication. Medical devices like pacemakers, defibrillators, implantable drug delivery systems, Neuro – stimulators have made life easy for patients with chronic conditions. Further advanced solutions like Smart Pills, wearable life recorders are designed to revolutionize the way healthcare is provided. The personal healthcare market is getting re-designed on wireless technology to suit the demands of the users.

As predicted by Parks Associates, the Wireless Homecare Devices US Market alone would stand at US $4.4Bn by 2013. According to Booz and Co, the Personal care and Home Equipment market was US $8.7 Billion in 2007 and would to grow to US$ 14.3 Billion in 2012.

While Wireless Technology offers ‘ease of use’ to the user, it also makes him vulnerable to security issues like eavesdropping, data theft and integrity.

If some unscrupulous element establishes unauthorized communication with a patient’s implantable drug delivery system controlled by the physician’s handheld unit and sends a wrong signal to deliver more drugs, the result could be adverse to the patient’s health, even fatal at times.

Or take a hypothetical situation where a diabetic monitors his blood glucose level every day at home and uploads the same info wirelessly to his personal health record through a wireless web interface. A hacker strikes in between. He exploits the vulnerability in the wireless communication, breaks into the personal health records and departs with the patient’s personal details like Social Security Number and even Credit Card details leaving the patient facing a possible situation of identity theft and financial loss.

So does a common man stop using wireless communication all together? What happens to the lifestyle we are used to? Do we let it go or be vulnerable to breach of our security? The debate is still on.

Let’s look at what the Government Agencies are doing in terms of regulations:

- FDA has taken steps towards regularizing wireless communication in medical devices. The first steps were taken way back in 1998 when DTV signals started interfering with work in hospital in Texas.

The purview of regulation for FDA and FCC is broadly defined along below mentioned lines. General-purpose communications devices are regulated by FCC. Medical devices that critically monitor patient health or provide treatment or therapy are regulated by FDA. Devices that do provide critical care and also use communications, such as life-critical wireless devices like remotely controlled drug-release mechanisms, are regulated by both agencies. In addition, device applications that would not be governed by FCC but transmit over wireless networks might warrant FDA oversight, while FCC might have better capability to assess the reliability of their Communications capability.

Present FDA guidelines talk about design requirements for wireless medical devices on issues like coexistence of RF and Wireless (Medical band, Wi-Fi, Bluetooth), EMI/EMC. While it mentions security as a feature, it doesn’t delve deep into bringing design requirements. What it has done is jointly organized a public meeting to bring all stakeholders on the same platform on issues ranging from data integrity, reliability, system security, spectrum allocation, risk management by defining level of criticality of device function as of July 2010.

Is this good enough of FDA or FDA needs to move real fast in a proactive manner than a reactive way to meet market situations?

Let’s now see what could be a technically possible solution.

We are looking at fulfilling two objectives. Conceal “patient device” information and secure the “patient data” communicated through the device. Prior information on Patient Device may help exploit the known vulnerabilities and “patient data” is highly sensitive info with multiple implications.

Key-based encryption would be the first possible solution that comes in one’s mind for securing patient data. However, it’s been proven to be vulnerable to failure through data “traffic pattern” analysis. The fallback option is masking pattern through cover traffic.

K- Anonymous message transmission can also be employed to secure “patient device” info. Here, the possible adversary can narrow down to the possible “patient device” to set of size k. Mixes could be used to further anonymize sender traffic.

However, all this would also mean greater burden on device critical resource like battery life or would need additional hardware/resource in the device.

The HCL solution team is closely monitoring the developments in the industry and is studying changes as industry leaders deliberate on the possible options. Important questions to be answered are how much is desirable and how much is too much. This is critical to set the perspective in this context. What do you think?

Related Posts:

• No Related Posts