This week’s blog is written by Connie Pilot, executive vice president and chief information officer at Inova Health System. Pilot will be sharing her expertise on the “The Coming Storm from IoT” panel at the Capital Cybersecurity Summit on November 2-3, 2016


Pilot_Connie UpdatedWith billions of data-generating devices connected to the Web, the Internet of Things (IoT) is changing the way we do business. No industry is immune, including healthcare. The Food and Drug Administration estimates that 500 million people around the world use some sort of mobile health app on their smartphones and millions more have embraced wearable health technology. Inside the hospital, Internet-connected medical devices such as MRI machines, CT scanners and dialysis pumps provide critical patient monitoring and support and as wireless technology proliferates in healthcare, so too does risk. The Web is fertile ground for stolen medical records, which are now more valuable to hackers than credit cards. Providers must find new ways to secure private data in an ultra-connected world.

The IoT offers important benefits for healthcare delivery and efficiency. It provides new avenues for patient communication, improves patient engagement and compliance, and enhances value-based care and service. At Inova, we use it in many ways: to monitor fragile newborns in the neonatal intensive care unit, control temperature and humidity in the operating room, deliver pain medication post-operatively and measure heart rhythm in cardiac patients, to name just a few. Medical data tracking enables us to intervene when necessary to provide preventive care, promptly diagnose acute disorders or deliver life-saving medical treatment. The benefits extend beyond our hospital walls into the community, where the IoT drives telehealth advancements that improve access for patients, such as virtual visits, eCheck-In, patient portals and electronic health records.

Balancing the benefits of greater connectivity with the need to protect critical data is a growing priority for healthcare providers. Opportunities exist for instilling interoperability and security standards that will seamlessly facilitate the sharing of necessary patient care information, while continuing to safeguard it from cyber-attacks.

Enabling connection and communication among different information technology systems and software applications can be daunting. While healthcare organizations can use proven security protocols in other domains, differences between IoT devices and traditional computing systems pose significant challenges. The IoT introduces innovative technology that requires emergent, often untested, software and hardware. Wearables, such as consumer fitness trackers and smartwatches, are a case in point. They present non-traditional access into the technology environment. While they use existing communication protocols that can be secured, there are challenges with multi-factor authentication and control of the devices in case of loss or theft.

Additionally, with millions of people using wearables, the volume of data generated can easily overwhelm an organization’s network, leaving it vulnerable to a potential denial of service attack. In this scenario, hackers attempt to prevent legitimate users from accessing information or services. Methods must be developed to limit data transmitted from wearables solely to those devices that should be transmitting and solely to information that is required for patient care.

Clearly, developing new methods of securing devices and the information they generate is a formidable task. We are fortunate to do business in an area that is well positioned to tackle this growing cybersecurity threat. With one of the most sophisticated technology workforces in the country, pioneering start-ups, world-class educational resources and a large government infrastructure, the National Capital region stands at the epicenter of innovation, policy and research. Our collective expertise can help us meet healthcare privacy and security challenges, and keep our patients and community safe.

 

Connie Pilot is executive vice president and chief information officer at Inova Health System. As the leader of Inova’s technology services division, she oversees all aspects of technology, including IT applications, change and quality management, information security, enterprise architecture, service delivery and informatics. 

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This week on NVTC’s blog, Gabriela Coman, partner and co-chair of Rubin and Rudman’s Intellectual Property Practice in Washington, D.C., discusses the ever-expanding field of medical device wearable technology and the important intellectual property implications around these devices.


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Wearable devices such as personal health monitoring, prevention and management devices, as well as methods of using such wearable devices, have become part of our everyday life and essential tools of modern medicine. From head-mounted display devices such as Google Glass or Oculus Rift to bracelets such as Fitbit or Garmin, wearable devices have also become part of an increasingly competitive and litigious environment, especially when competitors enter the market.

To become successful in the marketplace, a wearable device company needs a superior product and patent protection for its wearable device and related methods of use, both in the United States and abroad.

Patents are critical. A patent is a legal right that excludes others from practicing, manufacturing and selling the technology claimed in the patent (the wearable device and/or method of use of the wearable device).To obtain such patent protection, a wearable device company must submit a separate patent application for each country (or region, in the case of the European patent application) in which it wishes to protect its investment and invention. The time, money and effort required to obtain U.S. and international patents are important considerations because the process to obtain a patent requires a significant investment after filing the application.

Without patent protection, the costly product development for wearable devices may easily be copied by competitors. However, if the wearable device is patentable (and once it has been patented), the company will be able to (i) create legal barriers to entry for competing devices by preventing others from copying, selling or manufacturing the patented device; (ii) license the patented device to generate revenue; and (iii) enhance the value of the wearable device company by building equity in the company and creating assets that may attract other investments.

Before a wearable device company invests time and money to develop a wearable device and bring it to market (particularly for medical devices in the U.S. market that require FDA approval and clearance), the wearable device company should consider the following:

1.    What Are Wearable Devices?

Wearable devices encompass various technologies and systems that span numerous lifestyle applications including health and wellness, sports and fitness, home diagnostics, childcare, pet care, fashion and continuous lifestyle monitoring, among many others. These wearable, portable medical devices make it easier for people to assess their wellness, adopt better lifestyles and prevent the majority of diseases with early diagnosis and treatment. These wearable devices (when connected to a hospital or doctor) can also alert health professionals to various problems regardless of where the patient is located.

For example, a personal heart monitor like AliveCor Heart Monitor (FDA-approved for detection of atrial fibrillation) allows patients to monitor their heartbeat using an iPhone and provide the information to their doctors. The AliveCor Heart Monitor may be combined with its AliveECG app to provide a 30-second, one lead electrocardiogram in addition to recording heart rate per minute. In just 30 seconds, a patient could capture a medical-grade electrocardiogram and know instantly if the heart rhythm is normal or if atrial fibrillation is detected in the electrocardiogram. The AliveCor Heart Monitor operates remotely and includes a control unit wirelessly connected to a transmitter that could relay heartrate signals and electrical profile of the heartbeats, skin temperature and other measurements from a chest band or patch, for example.

Google Glass is another exemplary wearable device. As a head-mounted display device in the shape of a pair of eyeglasses, Google Glass allows medical personnel (surgeon) to view information relevant to a patient during surgery without having to turn away from the patient. As the projector display is next to the user’s right eye, the surgeon could see all medical information without looking across the room and away from the patient. The Glass projector could also display patient’s vital signs, urgent lab results and surgical checklists, along with relevant information on the specific surgical procedure. The doctor can control the device manually through voice commands and a touchpad located on its frame.

2.    Impact Of Wearable Devices On Health Information Technology

With the 2014 launch of the Apple Watch and its related Apple Health app (a health and fitness data dashboard) and HealthKit platform, many have predicted the beginning of a digital healthcare revolution. Indeed, wearable technology devices have impacted our personal lives in many ways providing insight into our health and diet regimen, blood pressure, sleep pattern, heart rate and many other life aspects. Wearable devices in the form of sport watches track steps and amount of calories burned; Doctor on Demand facilitates video conferences and live discussions with remote physicians; Google Glass facilitates surgery by offering surgeons information relevant to the patient without having to turn away from the patient; mobile health apps help patients stop smoking or lose weight (and can be installed either on a mobile phone or tablet).

Recently, medical device companies have promoted the use of biometric technology within people/patients. The idea is that sensors within the body could be used to call the healthcare provider if the person is sick. These sensors could be swallowed and placed in the blood or injected or inserted directly under the skin. The sensor can report when a patient ingested a prescription drug, as well as a patient’s vital signs. For example, a digital sensor recently approved by the FDA can be placed inside a pill and swallowed by a patient. Once the patient swallows the tiny digital device, the sensor transmits the identity of the medication and timing of ingestion to a mesh worn on the patient’s skin. The mesh then transmits the received information to a mobile phone app that can also provide physicians with vital signs such as heart rate, body temperature and various rest patterns.

Data from biometric digital sensors can be integrated with wearable devices to create new age health monitors that are further integrated with smartphone apps. Conventional health parameters such as glucose, blood pressure and heart rate can now be combined with environmental data to provide predictive as well as preventative information. In this manner, the emphasis is shifted from treatment to prevention of illnesses and diseases.

3.    Wearable Devices And Types Of Intellectual Property

Wearable devices in the medical field could be protected by various types of intellectual property including patents, copyrights and trademarks.

Utility patent applications may be filed to encompass various aspects of the device per se, such as components and specific structures of the wearable device, as well as designs of various components of the wearable device (through design patent applications).

Patent applications may be also filed to cover hardware of the wearable device such as software, interface, or materials and specialized particulates employed in the wearable technology.

A wearable device company may also apply for copyrights in various software for operating the wearable technology and device, and/or trademarks directed to branding. Considerations may be also given to the packaging of the device for possible protection by trade dress.

4.    Patent Protection For Wearable Devices

Wearable device are protected and patented in the U.S. and other countries.  However, methods or surgery and medical treatment methods are protected and patentable in the U.S. and Australia but typically not in Europe and other countries such as Canada, South Korea or Japan.

Utility patent applications may be filed directed to various aspects of the device per se, such as systems, sensors (electrical, optical or chemical sensors that monitor patient parameters), servers, accelerometers, actuators, materials, controls, kits or specific mechanical components of the wearable device, as well as designs of various structural components of the wearable device (through design patent applications).

Patent applications may also be directed to software, interface (iconic, graphical or numeric user interface with monochrome or color LCD display) or controller (high speed microprocessors or microcontrollers for analysis and data control) of the wearable device.

For example, US 8,764,651 entitled “Fitness Monitoring” discloses and claims inter alia a monitoring system with a portable device, one or more sensors and a processor; a system with a cellular telephone, an accelerometer and one or more sensors; and a system with a server, a portable appliance with a heart sensor and a processor. US 8,108,036 entitled “Mesh network stroke monitoring appliance” discloses and claims inter alia a monitoring system that includes one or more wireless nodes and a sensor coupled to a person to determine a stroke attack; as well as a heart monitoring system that includes one or more wireless nodes, a wearable appliance and a statistical analyzer. Similarly, USD 737159 and USD 764346 are examples of design patents that depict and claim ornamental design for wearable devices.

Medical device companies in the wearable technology field should protect all novel aspects of the wearable device including structural attributes and methods of use, as well as the ornamental look and design of the product. When possible, medical device companies should include claims that cover not only the product per se but also software that is within the app and the wearable device, without referring to the device, to preserve the right of the patent owner to sue the manufacturer of the software for direct infringement of the patent.

5.    Wearable Devices And Privacy Concerns

While wearable devices and biometric technology are redefining the information landscape offering many opportunities, they also pose several challenges.

One important challenge is protecting personal data and ensuring that the policies protecting the privacy and confidentiality of patients are evolving at the same pace as the expanding use of new technologies. Concerns are being raised as to where this personal data is stored and how it is being protected. Highly sensitive and personal data is constantly input into many smartphones with health apps which monitor an individual depending on the data that is inputted. The more data that is inputted, the more vulnerable the individual/patient becomes.

The digital format of data from wearable devices and biometric records opens a world of opportunities for hacking and data breaches, especially when the wearable device is linked with a smartphone, tablet and computer.

 

Gabriela I. Coman is partner and co-chair of Rubin and Rudman’s Intellectual Property Practice in Washington, D.C. Coman practices primarily in the intellectual property area, concentrating in the fields of medical, biotechnology, pharmaceuticals, chemical, semiconductors and design patents. Contact Gabriela Coman by email at gcoman@rubinrudman.com or by phone at 202.794.6300.

 

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