Dear Readers,
This edition of the CPI TechREG Chronicle concerns “Connected Healthcare” – namely how developments in technology and communications can facilitate the provision of key healthcare services to consumers. While connected healthcare services doubtless provide numerous benefits to patients and healthcare providers, they can also raise numerous regulatory challenges, as the authors of the pieces in this Chronicle set out.
Silvana Togneri MacMahon & Ita Richardson open, by providing a satellite view of how technology is changing the provision of healthcare. The authors present a definition of Connected Health, consisting of five components: Technology, Healthcare Pathways, People, Regulation and Data. Naturally, the article focuses on regulation – presenting the importance of recognizing how Connected Health solutions, given that they are Medical Devices in many cases, must be regulated.
Amy Durbin notes how the COVID-19 pandemic further ushered in an unprecedented era of change within the healthcare industry, particularly for telehealth. While pre-pandemic telehealth policy at the state and federal level often focused around payer reimbursement policies, attention during the pandemic has focused on state licensing and prescribing compliance across state lines. The article discusses ever-complicated and evolving medical privacy laws, as well as remaining broadband infrastructure and digital barriers.
Carol K. Lucas & Jennifer M. Guerrero discuss how U.S. health care providers are heavily regulated by an overlapping patchwork of laws, including fifty different sets of state laws. Technology has outrun the legal framework as providers seek to establish a digital healthcare practice. This complex web of overlapping and sometimes inconsistent laws makes establishing a multi-state medical practice challenging.
Turning to consumer technology, David Voran discusses issues surrounding Apple’s Health App, which is a pre-installed app on all iPhones. In essence, the app is a localized personal health tracker. It aggregates fitness and health related information from a growing number of applications and devices. Since 2018, the Health app has been able to download data from a patient’s health-system medical records using the persons active patient portal as validation and conduit. Later upgrades enable the user to select items in the Health app to share with their physicians. This functionality opens many clinical, regulatory, financial, and management questions.
Heinz Joerg Schwarz discusses how modern workflows that support interactive patient functionality and remote patient monitoring can be integrated with certain legacy infrastructure prevalent in many healthcare organizations. As the article notes, it is possible to seamlessly bridge between the two worlds and accomplish the goals of modern healthcare systems without a need to rip-and-replace reliable and scalable extant infrastructure. However, decisionmakers need to be mindful that connected healthcare today reaches beyond connecting systems inside a hospital system: it involves also connecting with the patient and a wider social community to accomplish better health outcomes.
Turning to specific aspects of patent law, Carl Kukkonen, Patricia Campbell & Gurneet Singh discuss drug discovery and artificial intelligence. In the pharmaceutical and biopharmaceutical industries, taking a drug to market is a quite often a tedious process. For example, to create a drug, scientists first predict one or more combinations of molecules that can be transformed into a drug. Next, scientists perform experiments on each molecular combination to test for efficacy. AI can greatly expedite this process, but the use of AI (rather than a traditional scientist or inventor) raises intriguing questions as to the patentability of drugs.
Finally, Gabriëlle Speijer & Peter Walgemoed discuss how patients and healthcare professionals need to take the lead in determining how technology is used to serve human values and needs. All stakeholders contributing to health and care should follow the same value: the Hippocratic Oath. A mindset focused on return on data instead of return on investment is needed to exploit the anti-rival nature of data and their value for society.
As always, many thanks to our great panel of authors.
Sincerely,
CPI Team
