What are Regulatory Compliances for #Healthcare #Products? || EMed #HealthTech

What are Regulatory Compliances for #Healthcare #Products? || EMed #HealthTech

As in every industry, the healthcare industry is also ruled by certain regulations that determine what is legal and illegal. Every country has certain regulations the healthcare industry needs to follow while implementing healthcare #software #solutions. Here are 6 major healthcare #regulations :1. Health Insurance Portability and Accountability Act #HIPAA -…

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What's ahead for health IT policy and legislation in 2023 

What’s ahead for health IT policy and legislation in 2023 

With Congress providing telehealth waivers as part of its omnibus spending bill at the close of 2022, delaying the “telehealth cliff” for two years, HIMSS says it’s now ready to make the case for permanent reimbursement of virtual care.Also on its policy agenda for the year ahead: advocating for data standardization, offering input for interoperability rulemaking and engaging with agencies and states to increase telehealth access. We spoke with the HIMSS government relations team for their thoughts on those priorities and more in 2023 and beyond.
Making telehealth’s case for cost control
Telehealth has proven to reduce burdens on healthcare providers and improve…

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Episode 11: Examining the Impact of Proposed HIPAA Changes on Medical Records Requests

Episode 11: Examining the Impact of Proposed HIPAA Changes on Medical Records Requests

On this episode of Health+Tech, McGuireWoods partners Andrea Linna and Jonathan Ishee are joined by Zack Perry, senior vice president of strategy for HealthMark and president of the Association of Health Information Outsourcing Services (AHIOS). They will examine the impact of proposed HIPAA rule changes on medical records requests. Topics will include:1. Best practices for responding to patient medical record requests2. Interplay of access requests with health apps and APIs3. Compliance threats that pertain to medical record access4. How the HIPAA proposed rule may shift additional costs onto healthcare providers5. OCR’s “Right to Access Initiatives” and recent settlements against healthcare providers that fail to provide timely…

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Episode 10: A Look at the  Proposed HIPAA Changes

Episode 10: A Look at the Proposed HIPAA Changes

In this episode of Health+Tech, Andrea Lee Linna and Jonathan Ishee are joined by fellow McGuireWoods digital health team member Michael Paluzzi to discuss proposed HIPAA changes that may require covered entities and business associates to overhaul their HIPAA policies and procedures in 2022.After providing a high-level overview of the proposed changes, the podcast turns to a live recording of Andrea and Jonathan’s recent webinar, “Preparing for Major HIPAA Changes in 2022,” offering in-depth details about the proposed changes and how to prepare for them in the new year….

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Episode 9: Digital Health Trends and Issues for Life Sciences Companies

Episode 9: Digital Health Trends and Issues for Life Sciences Companies

In this episode of Health+Tech, McGuireWoods healthcare attorneys Janice Suchyta, Kate Hardey, Kae Gruner and Royce DuBiner discuss the latest digital health updates from the Food and Drug Administration and Federal Trade Commission. Join the conversation as we wrap up Cybersecurity Awareness Month and discuss the following topics:• FDA draft guidance on electronic health records and medical claims data• FDA new resource for approved artificial intelligence/machine learning medical devices• FDA Digital Health Center of Excellence• FTC rules for health apps outside of HIPAA…

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Episode 8: Telehealth Barriers During Covid-19

Episode 8: Telehealth Barriers During Covid-19

In this episode of Health+Tech, McGuireWoods healthcare partner Janice Suchyta talks to Michele Satterlund, senior vice president in the state government relations practice of McGuireWoods Consulting and a partner with McGuireWoods, on the emergence of telehealth, particularly during the pandemic. They also look at how telehealth is evaluated state by state and discuss the need for uniform best practices….

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Episode 7: Houston Ready to Become the Third Coast for Biotechnology

Episode 7: Houston Ready to Become the Third Coast for Biotechnology

In this episode of Health+Tech, McGuireWoods healthcare partner Janice M. Suchyta talks to Donna Chang, founder and CEO of Hope Biosciences. Donna discusses how Texas — particularly Houston — is making a name for itself in biotechnology by attracting research funding, supporting premier academic medical centers and welcoming investment by major pharmaceutical companies. Hope Biosciences, a stem cell biotechnology company that has flourished as part of the biotech cluster in the Houston area, is helping to make Texas the third coast for biotechnology….

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Episode 6: Health Information Exchange and Security

Episode 6: Health Information Exchange and Security

In this episode of Health+Tech, McGuireWoods partners Jonathan Ishee and Andrea Lee Linna talk to George Gooch, CEO of the Texas Health Services Authority (THSA), about their cybersecurity, health information exchange and pandemic surveillance initiatives. They also discuss:Information blocking rule complianceRecent Texas legislation (now signed into law) affecting healthcare breach notificationThe role of health information exchange in public health surveillanceTHSA initiatives using open-source digital health tools to provide real-time situational awareness to healthcare providers during the pandemic…

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Episode 5: Venture Capital in Digital Health

Episode 5: Venture Capital in Digital Health

For this episode of Health+Tech, please join Dr. Anwar Hussain, General Partner at RhythmVC, and McGuireWoods Chicago partner Andrea Lee Linna, as they discuss digital healthcare and the nuts and bolts needed to create better systems. Their discussion covers:What venture capital is looking for when investing in digital healthOpportunities for startups in healthcare business-to-business softwareHow healthcare regulations impact digital health investmentApplication of artificial intelligence, blockchain and the internet of things to healthcare data…

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Episode 4: Exploring Recent Changes in Interoperability and Information Blocking

Episode 4: Exploring Recent Changes in Interoperability and Information Blocking

For this episode of Health+Tech, join Lauren Riplinger, vice president of policy and government affairs at AHIMA, and McGuireWoods healthcare partner Janice Suchyta, who co-leads the firm’s digital health group. Discussion will cover the following topics:The new Cures Act patient access rule and how to comply with the open notes requirementsTrends in health information interoperability among healthcare entitiesCompliance needs for information-blocking rules and exceptions…

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