WASHINGTON – The U.S. Department of Health and Human Services Office for Civil Rights has released guidance for health providers, payers and others when disposing of technology that contains electronic protected health information (ePHI). “Improper disposal of electronic devices and media puts the information stored on such devices and media at risk for a potential breach,” the guidance states. “Data breaches can be very costly to organizations.” Examples of digital equipment include desktop computers, laptops, tablets, smart phones, hard drives and USB drives. The guidance suggests that when disposing of technology that contains ePHI, providers and others should: determine and document the appropriate methods to dispose of the hardware, software and the data itself; ensure that ePHI is properly destroyed and cannot be recreated; ensure that ePHI previously stored on hardware or electronic media is securely removed so that it cannot be accessed and reused; identify removable media like CDs/DVDs or thumbdrives and their use; and ensure that ePHI is removed from reusable media before they are used to record new information.
AUSTIN, Texas – Xcertia, an industry and government collaborative that supports the development of guidelines around safe and effective mobile health applications, has added four new directors and two ex officio members to its board of directors. The new full members of the Xcertia board of directors are: Murray Aitken, executive director IQVIA Institute for Human Data Science; Ann Mond Johnson, CEO American Telemedicine Association; Dr. William Kassler, deputy chief health officer, IBM Watson Health; and Karen Dunn Lopez, Alliance for Nursing Informatics. “Working in collaboration with Xcertia helps to ensure that virtual care apps are developed and implemented within a consistent framework to the benefit of consumers, providers and technology developers alike,” said Johnson in a statement. The ex officio members are: Bakul Patel, associate director for digital health, Center for Devices and Radiological Health, U.S. Food and Drug Administration; and Dr. Andrew Gettinger, chief clinical officer, Office of the National Coordinator for Health Information Technology. “Bakul and Andrew will be key voices to influence and support how Xcertia evolves its mHealth guidelines,” said David Vinson, founding director and vice chairman of Xcertia, in a statement. “We believe it’s a significant step forward for the market when industry and government join forces to present a unified voice and positively affect the trajectory of the mobile health app market.” The new board members are now engaged in updating the draft guidelines released in December 2017.
CHICAGO – The American Medical Association has released a set of recommendations on augmented intelligence, a technology it says is designed to enhance human intelligence, not replace it.
“The promise of augmented intelligence in spurring technological innovation in medicine has generated growing interest among health care stakeholders,” said Dr. Jesse Ehrenfeld, AMA board member, in a statement. “It also has spurred a range of concerns about the novel challenges in the design, implementation and use—especially how AI will be incorporated into the practice of medicine and affect patients.”
The recommendations state the AMA will: leverage its ongoing engagement in digital health and other priority areas for improving patient outcomes and physicians’ professional satisfaction to help set priorities for health care AI; identify opportunities to integrate the perspective of practicing physicians into the development, design, validation and implementation of health care AI; promote development of thoughtfully designed, high-quality, clinically validated health care AI; encourage education for patients, physicians, medical students, other health care professionals and health administrators to promote greater understanding of the promise and limitations of health care AI; and explore the legal implications of health care AI.
The recommendations stress that AI systems need to be developed and evaluated in keeping with best practices in user-centered design, and usability should be tested by participants who are demographically representative of end users.
“As technology continues to advance and evolve, we have a unique opportunity to ensure that augmented intelligence is used to benefit patients, physicians and the broad health care community,” said Ehrenfeld. “Combining AI methods and systems with an irreplaceable human clinician can advance the delivery of care in a way that outperforms what either can do alone. But we must forthrightly address challenges in the design, evaluation and implementation as this technology is increasingly integrated into physicians’ delivery of care to patients.”
WASHINGTON – The U.S. Food and Drug Administration’s Center for Devices and Radiological Health recently announced it was expanding its medical software precertification program and establishing an incubator for digital health technology.
Experts are applauding the agency’s efforts to continue advancing innovation in health care.
“The government’s commitment is clear,” said Linda Pissott Reig, a shareholder at Buchanan Ingersoll and Rooney, a law firm whose clients include home care and hospice services, post-acute care facilities and medical device companies. “The FDA has undertaken many new initiatives that signal a proactive and thoughtful approach to spurring new medical devices and medical technologies.”
The FDA said it is expanding its precertification pilot program, drafted last year to enable a more streamlined review of their software as a medical device, to include: tools that have multiple functions; artificial intelligence-based tools; and digital therapeutic tools.
Nine companies were selected last year to take part in the pilot: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. The FDA hopes to add more companies and formally launch the expanded pilot by the end of the year.
“This regulatory attempt has the goal of moving the set point in the continuum of no regulation and extreme control toward a rational compromise between risk and cost and the speed of market availability,” said Dr. Joseph Roberson, chief medical officer of digital health platform provider VitalConnect. “A large number of differing medical technologies have brought about entirely new categories of devices and opportunities for device failure that has greatly complicated the FDA’s mission in recent years. I expect that trend will continue to accelerate.”
The agency also launched the Information Exchange and Data Transformation (INFORMED) incubator that will explore the use of real world data, biosensors, artificial intelligence and the Internet of Things to improve cancer treatment and drug development.
CHICAGO – Home health providers looking for guidance on remote patient monitoring systems will soon have an online resource from the Physician-Patient Alliance for Health & Safety.
The group will host the “Guide to Patient Monitoring, Improved Patient and Safety Outcomes” on its website to provide a forum for manufacturers, clinicians and the public to post and find information on patient monitoring devices, technology and solutions that are available or may become available on the market.
“We are often asked by our followers what patient monitoring systems we would recommend,” said Michael Wong, founder and executive director of the Physician-Patient Alliance for Health & Safety, an advocacy group dedicated to improving the safety and health of patients, and shedding light on prevention and other safety initiatives. “We are strong advocates for continuous digital monitoring of patients on opioids and other medications, and we hope that the guide will help with their decision-making process.”
PPAHS developed a standard set of questions and sent them to manufacturers of patient monitoring equipment. The guide will contain their answers.
Wong said the home health market is ripe for such a forum.
“Patients who are discharged to the home or other post-acute facility and their caregivers have questions about their medications and care plan,” he said. “We’ll be answering questions and posting articles that we hope will help.”
Wong said that while the industry has been slow to adopt patient-monitoring, the technology has already begun changing the way health care is delivered.
“It can’t be overemphasized that the real promise of technology is in giving us the ability for real-time monitoring of patients,” he said. “With patient monitoring, we can tell how the patient is doing through data and analytics, and then be able to adjust their treatment. They will get better care.”
WASHINGTON – Health experts are optimistic about the U.S. Food and Drug Administration’s guidance documents on digital health oversight released in December.
“These guidance documents take us one step closer to seeing a full integration of digital health into our lives,” said Kevin Madagan, a partner in Reed Smith LLP’s Life Sciences Health Industry Group.
The three guidance documents—two draft and one final—cover clinical decision support, changes to medical software policy based on congressional mandates in the 21st Century Cures Act, and Software as a Medical Device.
The draft guidance on clinical decision support, which has been six years in the making, clarifies which types of clinical decision support and patient decision support software the FDA defines as a medical device in need of agency oversight.
In a nutshell: Analytics technology intended to support clinical diagnoses that provides room for a physician to independently review the basis of the software’s recommendations would not be regulated by the FDA; however, software that analyzes medical images or laboratory or medical tests would remain regulated.
“This guidance, even in draft form, removes significant ambiguity,” said Madagan. “Until now, we didn’t know where the FDA would draw the line on CDS functions it would regulate, or whether they would ever agree to enforcement discretion for PDS.”
The other draft guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices. Among them: certain mobile apps.
“We’re making clear that certain digital health technologies—such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of the FDA’s guidance,” said Scott Gottlieb, FDA Commissioner, in a statement.
The final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.
Though the FDA guidance documents provide more clarity on digital health, Madagan said there is much work left to do.
“With advancements in digital applications being integrated into medical devices, and now even drugs, the digital oversight and real-time tracking of our health is just beginning,” he said. “And this doesn’t even account for the potential of artificial intelligence.”
SILVER SPRINGS, Md. – The U.S. Food and Drug Administration has released final guidance on the post-market management of marketed and distributed medical device cybersecurity.
“Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan,” said Dr. Suzanne Schwartz, the FDA’s associate director for science and strategic partnerships at the Center for Devices and Radiological Health, in a statement. “Today’s post-market guidance recognizes today’s reality–cybersecurity threats are real, ever-present and continuously changing.”
A key recommendation from the FDA is that medical device manufacturers should implement a structured and comprehensive program to manage cybersecurity risks. Other recommendations suggest that medical device manufacturers should: have a way to monitor and detect cybersecurity vulnerabilities in their devices;
understand, assess and detect the level of risk a vulnerability poses to patient safety; establish a process for working with cybersecurity researchers and other stakeholders to receive information about potential vulnerabilities; and deploy mitigations like software patches to address cybersecurity issues early, before they can be exploited and cause harm.
The FDA’s recommendations also state that it is vital for manufacturers and stakeholders across the entire ecosystem to consider applying the National Institute of Standards and Technology’s (NIST) core principles for improving critical infrastructure cybersecurity.
“It is only through application of these guiding principles, executed alongside best practices such as coordinated vulnerability disclosure, that will allow us all to navigate this uncharted territory of evolving risks to device security,” said Schwartz.
The FDA said that the new guidance applies to any marketed and distributed medical device including: medical devices that contain software (including firmware) or programmable logic; and software that is a medical device, including mobile medical applications.
The FDA’s guidance also applies to medical devices that are considered part of an interoperable system and to devices that are already on the market or in use.
“The same innovations and features that improve health care can increase cybersecurity risks,” said Schwartz. “This is why we need all stakeholders in the medical device ecosystem to collaborate to simultaneously address innovation and cybersecurity.”
DALLAS – A new multi-stakeholder collaboration, Xcertia, was established last week to improve the quality, safety and effectiveness of mobile health apps in a space where there has been little guidance or oversight. Dr. Eric Peterson, chairman of the Center for Health Technology & Innovation at the American Heart Association, an early supporter of Xcertia, spoke with us recently about why the alliance formed and what the future may hold for mHealth technology.
HHTN: Why was an alliance like this one necessary?
PETERSON: Our intent is to serve the marketplace in a positive way, working to bring meaningful clarity and focus to the mHealth space, advancing and enhancing innovative solutions that lead to better health tools and, ultimately, better health outcomes. With that in mind, the parties felt that a collaborative approach would best serve the intent.
HHTN: Do you think the home health technology space is in need of some safety measures/guidance?
PETERSON: We are excited about the depth and pace of health technology development and its application across the health continuum. That said, there can always be ways to improve and our desire is to do what we can to help the market fulfill the promise of technology—namely that by applying tech to health, outcomes can be meaningfully improved.
HHTN: How have mobile health apps impacted the home health care space?
PETERSON: We think mobile health apps have impacted the home health space by offering a unique opportunity to reach consumers where they are and in fairly real-time. The more meaningful and effective those apps can be, the better for both health outcomes and for consumers working to live healthier lives.
HHTN: What does the future of home health technology look like from your point of view?
PETERSON: We see great opportunity for a range of health solutions to provide ongoing help and support to patients and their families as they live their daily lives. There are also opportunities to create a health and data bridge between these solutions and the healthcare system. Smaller, faster, secure technologies as applied to home health and the ever-blending of consumer and patient-facing technologies will increasingly open opportunities for novel care solutions where care is most needed, wherever that may be.
WASHINGTON – A new multi-stakeholder collaboration will work to improve the quality, safety and effectiveness of mobile health apps in a space where there has been little guidance or oversight.
The new alliance, Xcertia, is supported by the American Medical Association, the American Heart Association, DHX Group and the Healthcare Information and Management Systems Society. It will not certify mobile health apps, but it will encourage developers and users to apply its guidelines and principles.
“There’s a lot of good content out there already,” said Dr. Michael Hodgkins, vice president and chief medical information officer for the AMA. “What’s missing is the evidence. No one has taken a comprehensive look at this and said ‘These are the things that need to be considered.’”
The alliance will incorporate feedback from members in a consensus-driven process to advance the body of knowledge for mobile health apps around clinical content, usability, privacy and security, interoperability and evidence of efficacy.
Hodgkins said the new alliance will look at the current mobile health app market to create and deliver detailed principles and best practices for developers and consumers.
“We’ll be asking questions like, ‘What’s the underlying evidence that supports what the app says it does?’ and ‘What will contribute to patient engagement?,’” said Hodgkins.
With the four non-profit organizations as founding members of Xcertia, the alliance will seek additional supportive members from the consumer, developer, payer, clinician, academia and home health care spaces. It will build a board of directors of about 15 individuals.
The alliance’s information and work will be published and available to the public on its website to advise and inform users of their choices, Hodgkins said.
“The mobile health app market is growing quickly,” said Hodgkins. “The home health area is especially ripe for these solutions as they are moving from analog to digital solutions and are able to engage patients virtually.”
CHICAGO – The American Medical Association recently released guidance on the safe and effective use of mobile health applications and other digital health devices. In a space that some in the industry are seeing as the “Wild West,” guidance on home health technology is necessary and timely, experts say.
“I think it’s exactly right,” said Dr. Joe Smith, CEO of Reflexion Health, makers of the VERA virtual exercise rehabilitation assistant. “The guidelines are pretty much on target.”
In a report presented at its 2016 Annual Meeting in October, the AMA recommends that mobile and digital health technology should, for example, support the establishment or continuation of a valid patient-physician relationship; have a high-quality clinical evidence base to support their use to ensure mHealth app safety and effectiveness; and follow evidence-based practice guidelines.
“I’m applauding all of it,” said Sam Zamarripa, president/director of Intent Solutions, maker of the TAD medication dispenser. “This industry is the future of health care and a social work approach is the right approach. It’s good; it’s an overdue step.”
While the AMA recognizes that “digital health has the potential to be integrated into everyday practice to promote improved patient health outcomes, support care coordination and improve communication,” it said in its report that there is a “need to balance these innovations with appropriate industry standards for mHealth apps and U.S. Food and Drug Administration of mobile medical devices.”
Smith believes that busy home health care workers are faced with a deluge of data and clinical information from home health devices on a daily basis. The AMA guidance, he said, will help them make better decisions about what tools they will use to find actionable data.
“We’re going to be asking more and more of technology to not only report data, but also put it into context,” he said. “The pressures on home health agencies are significant. Guidelines and safety measures now will help us all do better as an ecosystem as we begin to understand all of this.”
The AMA also recommends that mobile and digital health technology should: support care delivery that is patient-centered, promote care coordination and facilitate team-based communication; support data portability and interoperability to promote care coordination through medical home and accountable care models; abide by state licensure laws and state medical practice laws and requirements; require that physicians and other health practitioners delivering services through the app be licensed in the state where the patient receives services; and ensure that the delivery of any services via the app be consistent with the state scope of practice laws.