HomePortfolioPortfolio › WinGroup pharmaceutical

The adoption of digital health tools has skyrocketed in recent years, especially during the COVID-19 pandemic, which fueled the exponential growth of telehealth and remote care. Additionally, the rapid advancements in artificial intelligence (AI) technologies have further fueled this digital health revolution. These tools hold tremendous potential to enhance healthcare accessibility, improve efficiency in healthcare systems, and empower patients to take charge of their health. Therefore, it is imperative to establish consensus and standards for the development, testing, deployment, and governance of these technologies, considering the proliferation of unregulated digital health tools and the growing concerns around AI regulation.

The Role of Industry Collaboration:

To address the challenges faced by the healthcare industry in navigating the world of digital health and AI, several groups have emerged to provide guidance and support. Notably, the Health AI Partnership (HAIP), consisting of healthcare organizations and ecosystem partners such as DLA Piper, released a series of practical guides in May 2023. These guides outline best practices for the safe and effective adoption of AI solutions in health systems. Additionally, the Digital Medicine Society (DiMe) organized a group of healthcare experts who proposed the Evidence DEFINED Framework, aimed at evaluating the quality of digital health tools based on clinical evidence. These initiatives demonstrate the industry’s commitment to fostering informed decision-making and standardization in the digital health landscape.

HAIP Best Practice Guides:

HAIP, led by a diverse team of clinicians, engineers, lawyers, and social scientists from esteemed institutions like Duke Health, Mayo Clinic, and UC Berkeley, conducted extensive research to develop their best practice guides. Over 90 professionals from various healthcare and related fields participated in in-depth interviews, bringing expertise in areas such as bias, ethics, regulation, and credentialing.

Based on these insights, HAIP formulated a comprehensive collection of best practice guides that cover the entire AI product life cycle in healthcare settings. These guides outline eight decision points that healthcare professionals and organizations should consider when implementing AI tools:

1. Procurement: Identifying and prioritizing problems that AI can address and assessing the feasibility and viability of AI products.
2. Development: Defining success measures and designing AI solution workflows to integrate with existing operational structures.
3. Generate evidence of safety, efficacy, and equity: Validating AI products prior to clinical use and identifying potential risks.
4. Integration: Executing AI solution rollout and managing workflow changes to prevent misuse.
5. Lifecycle management: Monitoring AI solutions over time, updating or decommissioning them as necessary.

The publication of these guides aims to establish minimum elements for the governance of AI systems in healthcare settings and empower health system leaders to make informed decisions regarding AI adoption. Feedback on the guides is invited from healthcare professionals and the wider community, allowing for continuous improvement and refinement of the practices outlined.

DiMe Evidence DEFINED Framework:

Addressing the need for standardized evaluation criteria for digital health tools, the Evidence DEFINED Framework, developed by healthcare experts organized by DiMe, focuses on assessing the clinical evidence of digital health interventions (DHIs). Existing assessment frameworks were found lacking in their ability to evaluate digital tools effectively. Consequently, the Framework emphasizes clinical evaluation, efficient review processes, and the facilitation of standardized, rigorous DHI evidence assessment.

The Framework encompasses four essential components:
1. Data privacy
2. Clinical assurance and safety
3. Usability and accessibility
4. Technical security and stability

To enable stakeholders to make informed DHI selection decisions, the Framework proposes a four-step process:

1. Screen for absolute requirements: Identify threshold requirements that potential DHIs must meet, such as regulatory compliance.
2. Apply an established evidence assessment framework: Utilize existing evaluation frameworks designed for non-digital interventions.
3. Apply the Evidence DEFINED supplementary checklist: Supplement existing frameworks with specific concerns critical to digital health tools.
4. Make actionable recommendations: Provide evidence-based recommendations for appropriate levels of DHI adoption.

The Framework acknowledges the dynamic nature of the digital health space and establishes a collaborative platform for industry feedback and updates every 6 to 12 months. While the Framework’s focus is on clinical evidence, it encourages consideration of other domains, including health equity, patient experience, cost-effectiveness, and product design.

Implications and Conclusion:

The release of HAIP’s best practice guides and DiMe’s Evidence DEFINED Framework demonstrates the industry’s growing demand for evidence-based guidance and standardization in digital health. These resources hold significant value for health systems, payers, pharmaceutical and device manufacturers, and patients alike. Inclusive collaboration and regulatory expertise remain vital for successful implementation of digital health solutions.

It is essential for organizations seeking to adopt, implement, or stay current in the digital health landscape to utilize these resources as a foundation for their decision-making processes. However, it is equally important to continually assess and adapt these recommendations to real-world contexts. DLA Piper’s Digital Health and AI practices are well-equipped to provide strategic advice on digital health adoption, supporting the operationalization of industry best practices.

For further information regarding the HAIP guides, the Evidence DEFINED Framework, or DLA Piper’s Digital Health and AI capabilities, readers can reach out to their DLA Piper relationship partner, the authors of this article, or any Healthcare industry group member.

Blood vessels are the transport channels for human blood

Once the blood vessel is blocked

organ ischemia

cause various discomforts

even life-threatening

How to prevent blood vessel blockage?

How do keep blood vessels healthy?

Let’s answer them one by one

Thrombosis loves to find these types of people

Thrombosis is a small piece of blood formed on the surface of the inner surface of the cardiovascular system at the peeling off or repairing of the place. It is clinically divided into venous thrombus and arterial thrombus. Once the thrombus falls off, it will flow to various parts of the body with the blood, causing blockages, and resulting in no blood supply to the related organs.

For example, blockage in the brain can lead to cerebral infarction, blockage in the cardiovascular system can induce myocardial infarction, and accumulation in the lungs is pulmonary embolism.

The following categories of people are susceptible to thrombosis “preferred”:

• People with a genetic predisposition

Such people encounter other predisposing factors, such as increasing age, lower extremity sprain, long-term bed rest, pregnancy and childbirth, etc., which may lead to thrombosis.

• High blood pressure

Long-term elevated blood pressure can harden blood vessels, increase blood viscosity, and promote thrombosis. Long-term elevation or fluctuation of blood pressure can easily damage the vascular intima, cause atherosclerosis, and form a thrombus.

• Diabetic

Long-term high blood sugar can easily lead to arteriosclerosis and thickening of the arterial intima. Coupled with a hyperglycemic state, the fibrinolysis and coagulation systems may become unbalanced, resulting in increased blood viscosity, leading to thrombosis.

• Smokers

Nicotine, a harmful ingredient in tobacco, can damage the intima of blood vessels, causing lipids and inflammatory cells to accumulate in the blood vessels, thereby forming a mural thrombus. Nicotine stimulates vasoconstriction, making blood clots worse.

• People who sit or stand for long periods of time

When sitting for a long time, the muscle contractions of the legs decrease and the blood flow of the lower extremities slows down. Inactivity for 3 hours in a row will increase the risk of venous thrombosis; standing for a long time will make the calf muscles too tense, which will affect the blood flow and promote the formation of thrombosis.

• Those with a history of thrombosis

Patients with a history of blood clots are more likely to get another blood clot.

Several symptoms suggest blood vessels may be blocked

Early detection of the signs of vascular blockage and timely implementation of necessary measures is crucial to saving lives.

• Sudden chest tightness–Watch out for pulmonary embolism

If you suddenly feel chest tightness and tightness when you stand up after sitting or lying in bed for a long time, you should be alert to the possibility of pulmonary embolism caused by venous thrombosis in the lower extremities and blocking the pulmonary artery.

Pulmonary embolism is very dangerous and can lead to sudden death in severe cases. Therefore, if the above symptoms appear, you should seek medical attention as soon as possible.

• Chest pain–Suspected coronary heart disease, myocardial infarction

Coronary heart disease is called “coronary atherosclerotic heart disease”.

Coronary arteries are blood vessels that supply blood to the heart. If a blockage or stenosis occurs, the blood supply to the heart will be limited, and severe ischemia will result in chest pain.

• Weakness on one side–Beware of the heart attack

Sudden onset of weakness in one extremity (both upper and lower extremity) suggests a blockage of a cerebral or carotid artery. At the same time, it may also be accompanied by slurred speech, one side of the mouth and eyes, and blurred vision.

If these symptoms occur, regardless of whether they resolve on their own or not, please seek medical attention in time.

• Leg pain when walking–Watch out for blockages in lower extremity arteries

The arteries of the extremities are responsible for the blood supply to the upper and lower extremities. In the case of lower extremity vascular ischemia, leg pain may occur when walking, which can be relieved after rest, and then reappears when walking again.

If the blockage of the lower extremity arteries is ignored and the disease progresses further, it may lead to severe ischemia of the lower extremities, the skin temperature will drop, the pulse of the dorsum of the foot and the posterior tibial artery will weaken or disappear, and the lower extremity pain will also be felt at rest (ie, rest pain), and further development Limbs may rupture, wounds that do not heal, and even tissue necrosis (gangrene).

Diabetic patients are more likely to develop lower extremity lesions and must pay special attention.

Five details to raise healthy blood vessels

A healthy lifestyle can slow down vascular ageing

Be mindful of these habits

• Quit smoking

When smoking, harmful substances such as nicotine in tobacco will stimulate the vascular motor centre, and stimulate the release of epinephrine and norepinephrine in the body, causing the heart rate to increase peripheral vasoconstriction, and blood pressure to rise. Therefore, try not to smoke and stay away from second-hand smoke in your life.

• Healthy diet

Heavy-flavoured diets such as high oil, high salt, and high sugar will make the blood thicker and increase the burden on the blood flow. In life, eat more fruits and vegetables, and eat less greasy and fried food.

• Exercise regularly

Exercise can improve blood circulation, significantly reduce blood lipids, blood pressure and weight, relieve stress, and make you happy. It is recommended to choose aerobic exercise such as jogging, brisk walking, swimming, cycling, etc., for 30 minutes each time, 5 times a week.

• Work and rest rules

Staying up late can easily disrupt the biological clock, causing the body to secrete too much adrenaline and norepinephrine, thereby slowing blood flow and increasing its viscosity. Try to keep a regular schedule and go to bed before 11 pm.

• Regular physical examination

Develop a healthy concept of regular physical examination, pay attention to indicators such as body weight, waist circumference, blood pressure, blood lipids, blood sugar, etc., and control them within the normal range. Once the data is abnormal, consult a doctor in time, actively intervene and treat, and minimize the risk.

High Temperature

Increased threat to safe storage of hazardous chemicals

Must strengthen security protection

Do an excellent job of preventing heat and cooling

Prevent fire and explosion accidents!

Why is the storage of hazardous chemicals high in high-temperature weather?

• The increase in temperature increases the volumetric pressure of the hazardous chemical.

Thermal expansion and contraction are general physical phenomena of objects. The internal pressure of the container increases, and if it exceeds the limit that the container can withstand, it will cause the container to fail or even burst. If the container is open, the liquid contained in it expands beyond its capacity and will overflow, resulting in running, running, dripping and leaking. To prevent this from happening, in addition to taking measures to avoid heat and reduce the temperature, it is also necessary to carry out filling according to the specified filling coefficient. As far as the gas is concerned, its expansion coefficient is more significant, and the gas is generally contained in the cylinder. As the temperature rises and the pressure is too high, the cylinder is in danger of explosion.

• The rise in temperature makes the liquid evaporate faster

The higher the temperature, the faster the flammable liquid evaporates, the greater the concentration of vapour on the liquid surface, the greater the possibility of forming an explosive gas mixture with air, and the higher the risk of fire and explosion. The evaporation rate of different liquids varies with temperature, boiling point, specific gravity, and pressure. The ease with which a flammable liquid evaporates is expressed by its boiling point, the lower the boiling point, the more evaporative the liquid is. Some flammable liquids have very low boiling points, and once the ambient temperature exceeds its boiling point, it is prone to danger.

• Increased temperature accelerates oxidative decomposition and spontaneous combustion

Affected by environmental factors such as temperature and humidity, many dangerous chemicals are easily decomposed after being heated, releasing oxygen and even oxygen atoms, oxidizing other substances, and releasing a lot of heat at the same time. If the ventilation is poor, the heat will accumulate and not dissipate, causing the temperature to rise, which will speed up its oxidation rate, generate more heat, and promote the temperature to continue to rise. When the temperature reaches the spontaneous ignition point of the substance, it will spontaneously ignite.

What are the basic safety measures for the storage of hazardous chemicals?

• The storage warehouse should be qualified

Hazardous chemical warehouses should use non-conductive refractory materials as insulation layers for the roof and walls, and the eaves should be appropriately lengthened to prevent sunlight from entering the warehouse; the warehouse walls should be appropriately thickened, windows should be opened frequently, indirect ventilation holes should be used, and Double doors, double roof, window glass can be painted blue or frosted glass.

• Hazardous chemicals should be classified and stored

Hazardous chemicals are generally divided into explosive articles, combustible articles in contact with water, spontaneous combustible articles, flammable solids, flammable and combustion-supporting gases, corrosive articles, oxidants, etc. These items should be classified, stored in separate warehouses, divided into parts, and stored on separate shelves. It is strictly forbidden to mix items with conflicting properties, different fire fighting methods, and prone to spontaneous combustion.

When storing items, the stacking should not be too high, too large or too dense. A certain distance should be maintained between stacks, between stacks and walls, columns, roof beams and electric lights, and fire escapes should be reserved, and excessive storage should not be allowed.

• Strictly control the temperature

Set up a water storage roof for the warehouse or set up a cooling water pipe on the roof of the warehouse. When the temperature is above 30 degrees Celsius, the warehouse is cooled to keep the temperature in the warehouse below 28 degrees Celsius.

Laying sand and stone sacks on the roof of the warehouse can enhance the thermal insulation performance of the roof. The roof, exterior walls and window glass of the warehouse can also be painted white, and the reflection effect of white on sunlight can be used to reduce the absorption of radiant heat and achieve the effect of cooling.

According to the nature and packaging of the items, well water and ice cubes can be poured on the warehouse floor, and air conditioners can be installed to cool down if conditions permit. In some warehouses, windows can be opened in the morning and at night to let in cold air, and doors and windows can be closed at noon to prevent hot air from entering.

• Open storage yards and storage tanks to be cooled

Flammable liquids in barrels should be placed in buildings to prevent direct sunlight. In special circumstances, if it is necessary to temporarily store it in the open air, the sunshade should be built with non-combustible materials, and sometimes it is necessary to spray water regularly with a leather pipe to cool down according to the actual situation.

A cooling device should be installed on top of the storage tank. When the temperature reaches above 30 degrees Celsius, the cooling water pump should be turned on for spray cooling. The storage tank cannot be overfilled. Generally, only 90% to 95% of the volume is contained in the tank, and 5% to 10% of the volume space should be reserved, which can prevent the hazardous chemicals in the tank from burning or exploding due to thermal expansion.

• Install lightning protection facilities

Hazardous chemical warehouses are generally located at the edge of the unit or city, keeping a certain distance from other surrounding buildings. In this way, an open area is formed around the warehouse, which is vulnerable to lightning strikes. Therefore, the warehouse should install lightning protection devices to prevent fire accidents caused by lightning strikes.

• Strengthen personnel management

Personnel who manage hazardous chemical warehouses must undergo safety training, pass the examination, and hold certificates. Warehouse management personnel should regularly inspect the warehouse, find problems and solve them in time to ensure safety.

Check for these ten problems

• Low energy warehouse

The fire resistance level of the warehouse is not enough. According to the different risk factors of the stored substances, hazardous chemical warehouses have different fire resistance grade requirements, which should generally be above the second grade.

• Warehouse changed to factory

Illegal subcontracting or packaging of hazardous chemicals in warehouses.

• Special library to miscellaneous warehouse

Hazardous chemicals should be stored in special warehouses, but mixed with other items.

• Taboo warehouse

Store different types of hazardous chemicals in the same warehouse, such as hazardous chemicals with different fire fighting methods, acid and alkali, etc.

• Private and illegal warehouses

Privately build unapproved hazardous chemical warehouses or rent unsafe warehouses to store hazardous chemicals.

• Inhabited warehouse

Accommodation or offices in hazardous chemical warehouses.

• untagged warehouse

Items stored in hazardous chemical warehouses are not marked and labelled.

• Warehouse with the electrical threat

The power switch of the hazardous chemical warehouse is not set outside the warehouse, and the electrical circuits and lighting fixtures do not meet the explosion-proof requirements.

• Crowded warehouse

Hazardous chemical warehouse items are placed in disorder, and the “five distances” (top distance, lamp distance, wall distance, column distance, and stack distance) are insufficient. Flammable items should be placed at a fire distance.

• Open-air warehouse

Hazardous chemicals are stored in the open air without any protective measures.

Article source: https://mp.weixin.qq.com/s/4ovsj5Bsc83LaB_oZ9tSJA

The reaction of nitrogen-containing aromatic heterocyclic halides has been realized, which can be used for the synthesis of (S)-nicotine and its derivatives.

Since the beginning of this year, many places have started to plan detailed implementation rules and detailed work requirements. According to the actual situation of their administrative regions, the inspection of drug production, operation and use is further promoted.

Takeda China announced today that its innovative lung cancer drug Ambery® (brigatinib) was officially launched. Brigatinib, a novel selective ALK tyrosine kinase inhibitor, was approved by the China National Medical Products Administration (NMPA) in March 2022 as a single agent for anaplastic lymphoma kinase (ALK)-positive patients. For the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), its launch will further meet the unmet needs of Chinese ALK-positive advanced non-small cell lung cancer patients and help to develop a new treatment pattern in related fields.