By weighing security, safety, pairing, and ease-of-use considerations, manufacturers can engineer a thoughtful approach to implementing Bluetooth technology into their medical devices, fostering greater patient empowerment.
By Horst Merkle and Errett Kroeter
IMS Research suggests that the market for wireless patient-monitoring equipment is expected to grow to $9.3 billion by the end of 2014. Most experts agree that the catalyst for this growth is the number of people living with chronic diseases. The number of Americans living with chronic illnesses is expected to climb to 157 million by 2020, according to a paper published in Health Affairs titled “Confronting the Growing Burden of Chronic Disease: Can the U.S. Health Care Workforce Do the Job?”
|Pulse oximeters are among the medical devices that can communicate wirelessly using Bluetooth technology.|
As more people face chronic illnesses, medical device manufacturers operating in a vast, untapped healthcare ecosystem are tasked with developing technologies that improve patients’ lives. One technology for achieving this end is Bluetooth, a wireless technology standard for exchanging data over short distances from fixed and mobile devices. Bluetooth creates personal area networks with high levels of security. Suitable for use in health-monitoring devices, a more advanced version of Bluetooth—Bluetooth Smart—is a simple and secure connectivity solution that offers both power efficiency and a flexible application development framework.
During manufacturing, thoughtful consideration should be given to Bluetooth implementations in order to deliver successful products and optimize opportunities. Consequently, manufacturers should give careful consideration to such issues as power consumption, ease of use, security, and privacy, enabling them to lay the foundation for long-term gains benefiting both patients and company stakeholders.
Lithium ion AAA batteries can be an attractive option when powering such wireless devices as glucose meters and pulse oximeters. However, while they are inexpensive and readily available, such batteries are bulky, resulting in medical devices with large footprints and rendering them inconvenient for daily use. In contrast, coin cell batteries such as those used in Bluetooth Smart devices are very small. And because Bluetooth Smart devices use less energy than devices using other connectivity systems, they last longer and are more compact and less obtrusive.
Security and Safety Issues
The increasing use of wireless connectivity technologies in the medical device industry raises a range of security and safety issues. Bluetooth technology uses 128-bit Advanced Encryption Standard (AES) encryption. Established by the National Institute of Standards and Technology (NIST), this standard protects data during transmission from one device to another. While no wireless technology is completely immune from attack, AES is among the most secure technologies available today.
Adding to the complexity of complying with standards and managing security concerns is the fact that there is no harmonized approach to privacy worldwide. Thus, while medical devices in the United States must comply with the Health Insurance Portability and Accountability Act (HIPAA), Europe has its own set of privacy and security regulations. In 2012, the European Commission unveiled a draft of the European General Data Protection Regulation, which will supersede the Data Protection Directive. In addition, privacy laws may limit what types of personal data can be stored and what types can be used for analytics. Medical device manufacturers that offer products for the global market need to maintain a flexible set of protocols and a system that reaches the appropriate balance between privacy and device utility.
Pairing and Ease of Use
Pairing a Bluetooth-enabled device with a hub generally involves two concerns: making pairing easy for the user and supporting a multidevice environment. For example, when a patient at a doctor’s office downloads data from a device onto the physician’s computer, both the patient and the device manufacturer face myriad challenges. With several other patients in the waiting room—and even more in a hospital setting—several Bluetooth-enabled devices and hubs are likely to be engaged, overwhelming users and nurses. Thus, manufacturers must follow guidelines and standards for multidevice environments that support secure, reliable, and simple pairing—in the home, office, or hospital.
In medical device environments, manufacturers must also consider the special challenges involved in sharing sensitive medical information. The good news is that because of the use of adaptive frequency hopping and Secure Simple Pairing (SSP), Bluetooth technology is more reliable and more secure than other technologies. SSP provides multiple association models, depending on the security requirements of the device and user interface capabilities. Manufacturers can also choose to add additional security layers on top of Bluetooth Smart technology.
Horst Merkle is the director of diabetes management systems and diabetes care at Indianapolis–based Roche Diagnostics Corp. He is responsible for the initiation, definition, and development of key components of the company’s diabetes management solutions product portfolio, focusing on interoperability/connectivity, standardization, and mobile- and cloud-based applications. Merkle is a member of the Continua Health Alliance board of directors. He has also served on the executive committee of the Connectivity Industry Consortium, which developed the accredited POCT-1 standard for point-of-care systems interoperability. He has bachelor’s degrees in organic chemistry and business administration. Reach him at email@example.com.
Errett Kroeter is director of industry and brand marketing at the Kirkland, WA–based Bluetooth Specialist Interest Group (Bluetooth SIG), a body that oversees the development of Bluetooth standards and the licensing of Bluetooth technologies and trademarks to manufacturers. With more than 20 years of experience in business-to-business technology marketing, he is responsible for the worldwide branding strategy for Bluetooth. He has also led global marketing initiatives in such companies as Gateway and IBM Software. Kroeter received a master’s degree in business administration from the University of Colorado. Reach him at and firstname.lastname@example.org.