The Rocky Road of Evaluation for Digital Health Tools

Recent comments linking digital health tools to so-called “snake oil” has the channels of social media atwitter.  (Add this post to the noise!)  While some may decry the comparison, there is a lot we can learn from that perspective.

One of the challenges of broad digital health adoption is the simple fact that digital health encompasses such a broad array of technologies, usages and purposes.  There is no one tonic that will cure a list of ailments; rather we are presented with shelves of solutions to even more shelves of challenges waiting to be addressed.  Digital health includes, by my definition, the application of social media tools to preventative health and chronic disease management measures, as well as highly sophisticated data analytics applied to massive amounts of population health data to identify important health trends.  It also includes home monitoring devices that keep health care providers informed of their patient’s at-home health condition, as well as telestroke programs that allow physicians to access needed expertise.  The list is potentially endless, as new technologies created to address health issues and existing technologies are being put to use in the health care context. Continue Reading

AMA Approves New Ethical Guidance Policy and Encourages Telemedicine Training for Students and Residents

New Ethical Guidelines

On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on a report from the AMA Council on Ethical and Judicial Affairs and builds upon the AMA’s 2014 telemedicine guidance.

Consistent with past guidance from AMA and other professional organizations, the AMA notes that the ethical responsibilities of physicians are the same – regardless of whether the physician communicates with a patient in-person or remotely – and encourages providers to recognize the potential uses and limitations of technology when delivering care. “Telehealth and telemedicine are another stage in the ongoing evolution of new models for the delivery of care and patient-physician interactions,” said AMA Board Member Jack Resneck, MD. “The new AMA ethical guidance notes that while new technologies and new models of care will continue to emerge, physicians’ fundamental ethical responsibilities do not change.”

The 2016 policy recommends that once a patient-physician relationship is established, physicians who engage in telemedicine by responding to individual health queries electronically or providing clinical services through telemedicine:

  • Must disclose financial or other interests in certain telemedicine applications or services
  • Must protect patient privacy and confidentiality
  • Should inform patients of the limitations of the telemedicine encounter
  • Should encourage patients to inform their primary care doctor about the encounter
  • Should advise patients how to arrange follow-up care
  • Should, when necessary, recommend the use of a telepresenter or other health care professional at the originating site (e., the patient’s physical location)

Notably, the 2014 guidance required that a patient-physician relationship be established prior to the provision of telemedicine services. The relationship could be established during a face-to-face examination, through a consultation with another physician, or by meeting the evidence-based practice guidelines developed by major medical specialty societies. While the 2014 guidance did not specify whether the face-to-face examination must occur in-person, rather than digitally, many interpreted this requirement to be satisfied via an interactive telemedicine encounter.

In addition, the 2016 policy formally recognizes the importance of a “coordinated effort across the profession,” which includes clarifying standards and promoting access to technology. That said, the 2016 policy still requires the licensure of physicians in the state in which the patient is located. (As a general rule, physicians that practice telemedicine are subject to the licensure rules of both the state in which their patient is physically located and the state in which the provider is practicing.)  One potential avenue for facilitating multi-state licensure is the Federation of State Medical Boards’ Interstate Medical Licensure Compact, which offers a streamlined licensure process in each Compact state. The Compact has been adopted by 17 states thus far and more are expected to join this year and in 2017.

In sum, the AMA’s new ethical guidance should help physicians to better understand how their fundamental ethical responsibilities may play out differently when patient interactions occur through technology, and how this technology can be used to deliver more accessible, efficient and effective care.

Telemedicine Training for Students and Residents

Two days after adopting the ethical guidelines above, the AMA adopted a second telemedicine policy encouraging the inclusion of telemedicine training into undergraduate and graduate medical programs.

Since the vast majority of medical students are not learning about the potential benefits and appropriate uses of telemedicine technologies during medical school and residency, they are learning about telemedicine “on the job,” which may create missed opportunities for its use.  “As innovation in care delivery and technology continue to transform health care, we must ensure that our current and future physicians have the tools and resources they need to provide the best possible care for their patients,” said AMA immediate past president Robert M. Wah, MD  “In particular, exposure to and evidence-based instruction in telemedicine’s capabilities and limitations at all levels of physician education will be essential to harnessing its potential.”

In sum, the hope is that integrating formal telemedicine training into medical education programs will better prepare future physicians to appropriately and effectively integrate telemedicine into their clinical practices.

MaryKathryn Hurd, summer associate in McDermott’s Chicago office, co-authored this post.

Louisiana Joins its Peers in Removing In-State Barriers to Telemedicine

Last week, Louisiana legislators approved the removal of certain restrictions on the delivery of telemedicine services to residents of Louisiana to encourage the provision of telemedicine services in the state.  H.B. No. 570 was signed by the President of the Senate on June 5, 2016 and sent to Governor John Bel Edwards on June 6, 2016.

Notably, the Bill modifies the telemedicine requirements under La. Stat. Ann. § 37:1271, and R.S. 40:1223.3(5) and 1223.4(A) as follows:

  • A physician practicing telemedicine in the state who does not maintain a physical practice location within the state of Louisiana (but who is licensed in the state and has access to the patient’s medical records) is no longer required to first conduct an in-person patient history or physical examination of the patient before engaging in a telemedicine encounter.
  • In sum, La. Stat. Ann. § 37:1271 now requires that telemedicine providers hold an unrestricted license to practice medicine in Louisiana; obtain access to the patient’s medical records upon consent of the patient; create a medical record on each patient and make it available to the Louisiana State Board of Medical Examiners upon request; and, if necessary, provide a referral to a physician or arrange follow-up care in the state, as indicated.
  • The definition of “synchronous interaction” found in S. 40:1223.3(5) is now broadened to allow providers to use audio (without video) for telemedicine encounters if the same standard of care as in-person encounters is maintained.
  • This means that patients will be able to use a phone for telemedicine purposes, which is especially useful for patients who may not have: access to video-based technology, the know-how to connect with a provider using video-based technology, or an appropriate data plan/wireless connection for the simultaneous transmission of video.
  • Each state agency and each professional or occupational licensing board or commission authorized to adopt rules and regulations specific to the practice of telemedicine pursuant to S. 1223.4(A) is now prohibited from adopting any rules or regulations that are more restrictive than the provisions of the present law.

Like Alaska’s recent modifications to its telemedicine requirements, the Louisiana Bill broadens the base of available health care providers through the removal of the in-state restriction, which helps to increase the supply of physicians and competition from lower-cost providers, reduces transportation costs and improves access to quality care.  In addition, this Bill expands the types of technologies that may be used to deliver telemedicine services, which will better accommodate the significant portion of health care consumers who prefer phone consultations to access care.

Mobile Health Tools, Developers Need Better Data Protection Guidance, Attorney Jennifer Geetter Says

After three government agencies collectively created an online tool to help developers navigate federal regulations impacting mobile health apps, McDermott partner Jennifer Geetter was interviewed by FierceMobileHealthcare on the need for mobile health development tools.

Read the full article from FierceMobileHealthCare.

FTC Weighs-in on Telehealth: Providing Comments Regarding Alaska’s Proposed Licensure and Standard of Care Requirements

In March 2016, the US Federal Trade Commission (“FTC”) staff submitted public comments regarding the telehealth provisions of a proposed state bill in Alaska demonstrating the FTC’s continued focus on health care competition and general discouragement of anti competitive conduct in health care markets, with a renewed interest and focus on telehealth.

Continue Reading

Developing and Implementing an Effective Telemedicine Informed Consent Form

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the increased use of telemedicine by providers to reach patients who were previously out of reach, and to provide more timely and cost-effective care.

With the use of telemedicine technologies comes a responsibility on the part of providers to educate and inform patients on the benefits, and more importantly, on the risks associated with receiving care via telemedicine. Like any other care setting, compliance with this responsibility serves the dual purpose of providing consumers with the information needed to make an informed decision about their care, but also mitigates the provider’s potential liability exposure from medical malpractice claims. Continue Reading

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps that collect, create and share consumer information, including health information. The interactive series of questions and answers augments and cross-references existing guidance from the US Department of Health and Human Service (HHS) that helps individuals and entities—including app developers—understand when the Health Insurance Portability and Accountability Act (HIPAA) and its rules may apply.  The tool is also intended to help developers determine whether their app is subject to regulation as a medical device by the FDA, or subject to certain requirements under the Federal Trade Commission Act (FTC Act) or the FTC’s Health Breach Notification Rule. The Commission developed the tool in conjunction with HHS, FDA and the Office of the National Coordinator for Health Information Technology (ONC).

Based on the user’s response to ten questions, the tool helps developers determine if HIPAA, the Federal Food, Drug, and Cosmetic Act (FDCA), FTC Act and/or the FTC’s Health Breach Notification Rule apply to their app(s). Where appropriate based on the developer’s response to a particular question, the tool provides a short synopsis of the potentially applicable law and links to additional information from the appropriate federal government regulator.

The first four questions cover a developer’s potential obligations under HIPAA. The first question explores whether an app creates, receives, maintains or transmits individually identifiable health information, such as an IP address. Developers may use the tool’s second, third and fourth questions to assess whether they are a covered entity or a business associate under HIPAA. The tool’s fifth, sixth and seventh questions help developers establish whether their app may be a medical device that the FDA has chosen to regulate.  The final three questions are intended to help users assess the extent to which the developer is subject to regulation by the FTC.

Although the tool provides helpful, straightforward guidance, users will likely need a working knowledge of relevant regulatory principles to successfully use the tool.  For example, the tool asks the user to identify whether the app is “intended for use” for diagnosis, cure, mitigation, treatment or disease prevention, but does not provide any information regarding the types of evidence that the FDA would consider to identify a product’s intended use or the intended use of a mobile app (e.g., statements made by the developer in advertising or oral or written statements). In addition, how specifically an app will be offered to individuals to be used in coordination with their physicians can be dispositive of the HIPAA analysis in ways that are not necessarily intuitive.

The tool provides a starting point for developers to raise their awareness of potential compliance obligations. It also highlights the need to further explore the three federal laws, implementing rules and their exceptions. Developers must be aware of the tool’s limitations—it does not address state laws and is not intended to provide legal advice. In fact, the tool does not provide links to the actual text of the laws or regulations and is clearly aimed at non-lawyers.  Nor does the tool highlight all applicable guidance documents provided on the websites for each federal regulator, which shed additional light on what that regulator has determined is within or outside of its oversight.

FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel infrastructure to conduct post-market effectiveness studies.

Sentinel is an electronic surveillance system that aggregates data from electronic medical records, claims and registries that voluntarily participate and allows the agency to track the safety of marketed drugs, biologics and medical devices. As of August 2015, the Sentinel database includes information from 193 million individuals, 4.8 billion instances of prescription dispensing, 5.5 billion unique encounters and 51 million acute inpatient stays.

The FDA currently uses the system to assess post-market safety issues. However, in a February 3, 2016, workshop, Dr. Woodcock announced that the FDA is in the early stages of adapting the Sentinel infrastructure to develop the “Guardian” system, which the agency intends to use to “actively gather information about the performance of regulated medical products” used in health care. At the same workshop, Dr. Steven Anderson of the FDA’s Center for Biologics Evaluation and Research (CBER) described the Guardian system as a parallel system to Sentinel that will rely on the Sentinel infrastructure to assess product effectiveness. According to Dr. Anderson, the FDA is currently assessing the feasibility of using Sentinel to perform effectiveness studies, and over the next five years, intends to develop the system to support a range of clinical trial designs.

The FDA envisions that the Guardian system will help the agency and external researchers quickly and less inexpensively answer questions about the performance of medical products that would otherwise require expensive, time-consuming clinical investigations to assess. The FDA did not specifically address how the agency intends to use the effectiveness data developed using the Guardian system.

The proposed Guardian system represents the FDA’s latest attempt to harness the power of “big data” and to participate in the changes precipitated by digital health strategies and tools to address FDA priorities. In 2014, the FDA launched its openFDA initiative, which gives the general public access to several of the agency’s public data sets (e.g., adverse event reports). Moreover, in December 2015, the FDA launched a beta version of its precisionFDA platform, which is an online, cloud-based platform that is intended to allow scientists from the public and private sectors to test, pilot and validate existing and new bioinformatics approaches for processing the large amounts of data collected using next-generation sequencing (NGS) technology.

The FDA’s efforts to launch the Guardian system mirror “big data” initiatives by other private and public stakeholders seeking to leverage data capture and data mining to pursue important public health, quality improvement, research and cost-containment efforts.

New Year, New Telehealth Opportunities

As we reflect upon how the health care industry has changed in 2015 and what we expect to see in 2016, there is one area that stands out as having great promise for continued growth—telehealth.

  • There were more than 200 telehealth-related bills introduced in 42 states in 2015, many of which helped to encourage the growth and expansion of telehealth. More than half of the states now have laws that mandate some degree of coverage of telemedicine programs by private payers. In addition, nearly a quarter of the states have joined the Interstate Medical Licensure Compact, which provides a more streamlined licensure process for physicians who are located in a “Compact state” and who provide telemedicine services to residents of another “Compact state.” In 2016, we expect even more states will adopt laws to require health insurance coverage for telemedicine services and ease the licensure requirements for health care professionals who are engaged in multi-state telemedicine programs. See our article, “States Begin 2016 with the Expansion of Telehealth Services,” for additional details.
  • There has been a marked increase in consumer investment in personal health and wellness, partly as a cost reduction strategy in light of high-deductible health plans, over the past few years. Consumers are particularly excited about the possibilities of telehealth, which has spurred the expansion of direct-to-consumer telehealth programs. In 2016, we anticipate an increase in the number of consumers who use telehealth services, as well as an increase in the types of telehealth technologies used.
  • An increasing number of employers—ranging from big to small—offered telemedicine as a benefit to employees in 2015 in an effort to reduce health care costs and as a means of improving employee health. Given the broad breadth of coverage included in the cost of employer-sponsored coverages, and the desire for employers to improve employee health to increase productivity and satisfaction levels, we anticipate that even more employers will turn to telemedicine as a solution in 2016.
  • The telehealth programs of accountable care organizations (ACOs) and clinically integrated networks (CINs) proved to improve patient access to care (particularly in the area of behavioral health) and deliver quality care at a lower cost—a critical imperative in the post-Accountable Care Act era of value-based purchasing. The realization of these benefits in 2015 will likely contribute to an increase in the number of ACOs and CINs using telemedicine as a tool in 2016.
  • There was a marked rise in 2015 in the number of partnerships between U.S. health care providers and international institutions for U.S. physicians (particularly in certain orthopedic and oncology sub-specialty areas) to provide consultations to international physicians about their patient cases, as well as “second opinion” programs where U.S. physicians review the medical records and diagnostic tests of patients located abroad, and then render a second opinion to that patient. We anticipate that these international telemedicine arrangements will continue throughout 2016 as U.S. providers search for ways to expand their patient base and grow their brands internationally.

If these telehealth trends continue in 2016 as anticipated, there is reason to remain optimistic that providers, patients, and entrepreneurs will continue developing and using telehealth in a way that positively changes the U.S. health care industry.

Farewell ‘Safe Harbor,’ Hello ‘Privacy Shield’: Europe and U.S. Agree on New Rules for Transatlantic Data Transfer

After intense negotiations, and after the official deadline had passed on Sunday, 31 January 2016, the United States and the European Union have finally agreed on a new set of rules—the “EU-U.S. Privacy Shield”—for data transfers across the Atlantic. The Privacy Shield replaces the old Safe Harbor agreement, which was struck down by the European Court of Justice (ECJ) in October 2015. Critics already comment that the Privacy Shield will share Safe Harbor’s fate and will be declared invalid by the ECJ; nevertheless, until such a decision exists, the Privacy Shield should give companies legal security when transferring data to the United States.

While a text of the new agreement is not yet published, European Commissioner Věra Jourvá stated that the Privacy Shield should be in place in the next few weeks. According to a press release from the European Commission, the new arrangement

…will provide stronger obligations on companies in the U.S. to protect the personal data of Europeans and stronger monitoring and enforcement by the U.S. Department of Commerce and Federal Trade Commission (FTC), including through increased cooperation with European Data Protection Authorities. The new arrangement includes commitments by the U.S. that possibilities under U.S. law for public authorities to access personal data transferred under the new arrangement will be subject to clear conditions, limitations and oversight, preventing generalized access. Europeans will have the possibility to raise any enquiry or complaint in this context with a dedicated new Ombudsperson.

One of the most known critics of the U.S. data processing practices and initiator of the ECJ Safe Harbor decision, Austrian Max Schrems, already reacted to the news. Schrems stated on social media that the ECJ Safe Harbor decision explicitly says that “generalized access to content of communications” by intelligence agencies violates the fundamental right to respect for privacy. Commissioner Jourová, referring to the Privacy Shield, stated that “generalized access … may happen in very rare cases”—which could be viewed as contradictory to the ECJ decision. Critics also argue that an informal commitment by the United States during negotiations with the European Union is not something on which European citizens could base lawsuits in the United States if their data is transferred or used illegally.

The European Commission will now prepare a draft text for the Privacy Shield, which still must be ratified by the Member States. The EU Parliament will also review the draft text. In the meantime, the United States will make the necessary preparations to put in place the new framework, monitoring mechanisms and new ombudsperson.

 

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